Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ] .
ELINEST TM is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
www.fda.gov/medwatchCigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications].
ELINESTTM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINESTTM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.
Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
Each pill pack contains 21 pale pink active tablets and 7 white inert tablets.
Mechanism of Action
Combined oral contraceptives (COCs) prevent pregnancy primarily by suppressing ovulation.
ELINESTTM is indicated for use by females of reproductive potential to prevent pregnancy.
In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
ELINESTTM is contraindicated in females who are known to have or develop the following conditions:
ºSmoke, if over age 35
ºHave deep-vein thrombosis or pulmonary embolism, now or in the past
ºHave inherited or acquired coagulopathies
ºHave cerebrovascular disease
ºHave coronary artery disease
ºHave thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation)
ºHave uncontrolled hypertension
ºHave diabetes mellitus with vascular disease
ºHeadaches with focal neurological symptoms or migraine headaches with aura
ºWomen over age 35 with any migraine headaches
Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings , Risk of liver enzyme elevations with concomitant hepatitis c treatment).
Impaired Liver Function
Do not use ELINESTTM in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver [see Contraindications]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue ELINESTTM if jaundice develops.
Liver Tumors
ELINESTTM is contraindicated in women with benign and malignant liver tumors [see Contraindications]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However the risk of liver cancers in COC users approaches less than one case per million users.
Risk Of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue ELINESTTM prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications]. ELINESTTM can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
ELINESTTM is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications]. For women with well-controlled hypertension, monitor blood pressure and stop ELINESTTM if blood pressure rises significantly.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing quantities of progestin.
Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.
Carefully monitor prediabetic and diabetic women who take ELINESTTM. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
If a woman taking ELINESTTM develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue ELINESTTM if indicated.
Consider discontinuation of ELINESTTM in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
Unscheduled Bleeding and Spotting
Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product.
In 1,287 patients (pooled data from a number of studies), unscheduled bleeding was recorded in 15% of first cycles and by Cycle 12 was 5%. In total, 23% of subjects reported spotting, 20% reported unscheduled bleeding, and 2% reported change in menstrual flow at some point in the studies.
In the studies, 1.2% discontinued use of the product due to breakthrough bleeding and 1% discontinued due to spotting.
Amenorrhea and Oligomenorrhea
Women who use ELINESTTM may experience amenorrhea. A total of 9% of subjects in the studies reported amenorrhea in one or more cycles.
Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent.
If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
Carefully observe women with a history of depression and discontinue ELINESTTM if depression recurs to a serious degree.
Breast Cancer
ELINESTTM is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications].
Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and also among current users with longer duration of COC use [see Adverse Reactions].
Cervical Cancer
Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking ELINESTTM.
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation:
Do not co-administer ELINESTTM with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings , Risk of liver enzyme elevations with concomitant hepatitis c treatment ).
Effects of Other Drugs on Combined Oral Contraceptives
Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Colesevelam: Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.
Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. Concomitant administration of CYP3A4 inhibitors such as itraconazole, fluconazole, grapefruit juice or ketoconazole may increase plasma hormone concentrations.
Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of the estrogen and/or progestin have been noted when COCs are coadministered with some HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir], or increase [e.g., indinavir and atazanavir/ritonavir] HCV protease inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).
Effects of Combined Oral Contraceptives on Other Drugs
COCs containing EE may inhibit the metabolism of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in the plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs.
The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.
Discontinue ELINESTTM use if pregnancy is confirmed.
Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.
Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.
Safety and efficacy of norgestrel and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older. Use of ELINESTTM before menarche is not indicated.
ELINESTTM has not been studied in postmenopausal women and is not indicated in this population.
See FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information:
An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives:
Adverse reactions commonly reported by COC users are:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of norgestrel and ethinyl estradiol tablets was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of norgestrel and ethinyl estradiol tablets for contraception. Subjects were exposed for a total of 11,085 cycles, with 429 women completing one year of exposure. Subjects ranged in age from 15 to 40 years. Demographics were 69% Caucasian, 28% Black, and 3% other.
Common Adverse Reactions (≥ 2% of women):
A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression.
Postmarketing Experience
Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.
RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
The following additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestrel and ethinyl estradiol tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Arterial Events: Arterial thromboembolism, Myocardial infarction, Cerebral hemorrhage
Eye Disorder: Optic neuritis, which may lead to partial or complete loss of vision, Intolerance to contact lenses, Change (steepening) in corneal curvature
Gastrointestinal Disorders: Colitis, Nausea, Pancreatitis
Hepatobiliary Disorders: Gallbladder disease, Cholestatic jaundice, Budd-Chiari syndrome
Immune System Disorders: Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
Metabolism and Nutrition Disorders: Carbohydrate and lipid effects, Porphyria, exacerbation of Porphyria
Neoplasms, Benign, Malignant, and Unspecified: Carcinoma of the reproductive organs and breasts, Hepatic neoplasia (including hepatic adenomas or benign liver tumors)
Psychiatric Disorders: Mood changes
Reproductive System and Breast Disorders: Temporary infertility after discontinuation of treatment, Changes in libido, Vaginitis, including candidiasis; Breast secretion
Skin and Subcutaneous Tissue Disorders: Melasma/chloasma, which may persist; Erythema multiforme, Erythema nodosum, Hemorrhagic eruption, Hirsutism
Vascular Events: Venous thrombosis, Pulmonary embolism, Cerebral thrombosis, Mesenteric thrombosis, Retinal vascular thrombosis
OVERDOSAGE
There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, ELINESTTM (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of ELINESTTM is one pale pink tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that ELINESTTM tablets be taken by mouth at the same time each day.
How to Start ELINESTTM
Consider the possibility of ovulation and conception prior to initiation of medication.
Instruct the patient to begin taking ELINESTTM on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (pale pink) is taken that day. The patient should take one pale pink tablet daily for 21 consecutive days followed by one white inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of pale pink tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on ELINESTTM for contraception until a pale pink tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days.
After the first cycle of use
The patient is to begin her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days of pale pink tablets, followed by 7 days of white inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a pale pink tablet daily for 7 consecutive days.
Switching from another hormonal method of contraception
Use after pregnancy, abortion, or miscarriage
If spotting or breakthrough bleeding occurs
If spotting or breakthrough bleeding occurs, instruct the patient to continue on the same regimen. This type of bleeding is usually transient and without significance; however, advise the patient to consult her healthcare provider if the bleeding is persistent or prolonged.
Missed Tablets
The possibility of ovulation and pregnancy increases with each successive day that scheduled pale pink tablets are missed. If withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (if she missed one or more tablets or started taking them on a day later than she should have), consider the probability of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in FDA-Approved Patient Labeling below.
Advice in Case of Gastrointestinal Disturbances
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].
ELINEST™ Tablets (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg): Each pale pink tablet is biconvex, round, with “E1” debossed on one side, and contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol. ELINEST™ blisters (NDC 16714-365-01) are packaged in cartons of one, three, and six 28-tablet dispensers. Each tablet dispenser contains 21 pale pink (active) tablets and 7 white (inert) tablets. Inert tablets are biconvex, round, with “P” debossed on one side and “N” on the other side.
ELINEST™ Tablets are available in the following:
Carton of 1 NDC 16714-365-02
Carton of 3 NDC 16714-365-03
Carton of 6 NDC 16714-365-04
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
FDA-Approved Patient Labeling
ELINESTTM [ee-lin-EST]
(norgestrel and ethinyl estradiol tablets)
What is the most important information I should know about ELINESTTM?
Do not use ELINESTTM if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
What is ELINESTTM?
ELINESTTM is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does ELINESTTM work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use norgestrel and ethinyl estradiol tablets.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Who should not take ELINESTTM?
Do not take ELINESTTM if you:
You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
If any of these conditions happen while you are taking ELINESTTM, stop taking ELINESTTM right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking ELINESTTM.
What should I tell my healthcare provider before taking ELINESTTM?
Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
ELINESTTM may affect the way other medicines work, and other medicines may affect how well ELINESTTM works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ELINESTTM?
Read the Instructions for Use at the end of this Patient Information.
What are the possible serious side effects of ELINESTTM?
Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:
Call your healthcare provider or go to a hospital emergency room right away if you have:
Other serious side effects include:
ºrare liver tumors
ºjaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
What are the most common side effects of ELINESTTM?
These are not all the possible side effects of ELINESTTM . For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088.
What else should I know about taking ELINESTTM?
How should I store ELINESTTM?
General information about the safe and effective use of ELINESTTM:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ELINESTTM for a condition for which it was not prescribed. Do not give ELINESTTM to other people, even if they have the same symptoms that you have.
This Patient Information summarizes the most important information about ELINESTTM. You can ask your pharmacist or healthcare provider for information about ELINESTTM that is written for health professionals. For more information, call 1-800-206-7821.
Do birth control pills cause cancer?
It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.
If you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
What if I want to become pregnant?
You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.
What should I know about my period when taking ELINESTTM?
Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking ELINESTTM, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.
What are the ingredients in ELINESTTM?
Active ingredients:
Each pale pink pill contains norgestrel and ethinyl estradiol.
Inactive ingredients:
Pale pink pills: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.
White pills: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
INSTRUCTIONS FOR USE
Important Information about taking ELINESTTM
BEFORE YOU START TAKING ELINESTTM
1.DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.
It is important to take it at about the same time every day.
2.LOOK AT YOUR PILL PACK:
The pill pack has 21 "active" pale pink pills (with hormones) to take for 3 weeks, followed by 1 week of reminder white pills (without hormones).
3.FIND:
1) where on the pack to start taking pills, and
2) in what order to take the pills (follow the arrows)
4. BE SURE YOU HAVE READY AT ALL TIMES:
•Another kind of birth control (such as condoms or spermicide) to use as a back-up in case you miss pills•An extra, full pill pack
WHEN TO START THE FIRST PACK OF PILLS
You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.
DAY 1 START:
1. Pick the day label strip that starts with the first day of your period. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the tablet dispenser.
Note: if the first day of your period is a Sunday, you can skip step #1.
2. Take the first “active” pale pink pill of the first pack during the first 24 hours of your period.
3. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.
SUNDAY START:
1.Take the first "active" pale pink pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
2.Use a non-hormonal method of birth control(such as condoms or spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).
WHAT TO DO DURING THE MONTH
1. Take one pill at the same time every day until the pack is empty.
Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
Do not skip pills even if you do not have sex very often.
2. When you finish a pack:
Start the next pack on the day after your last “reminder” pill. Do not wait any days between packs.
IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS:
If your previous brand had 21 pills: Wait 7 days to start taking ELINESTTM. You will probably have your period during that week. Ideally, be sure that no more than 7 days pass between the 21-day pack and taking the first pale pink ELINESTTM pill (“active” with hormone). If you start ELINESTTM more than 7 days after taking the last pill of your previous contraceptive, you must use a non-hormonal back-up method of birth control during the first 7 days of ELINESTTM use.
If your previous brand had 28 pills: Start taking the first pale pink ELINESTTM pill (“active” with hormone) on the day after your last reminder pill. Ideally, do not wait any days between packs. If you do skip any days between the last pill of your previous contraceptive and starting ELINESTTM, you must use a non-hormonal back-up method of birth control during the first 7 days of ELINESTTM use.
IF YOU SWITCH FROM ANOTHER TYPE OF BIRTH CONTROL METHOD:
If you were previously taking a progestin-only PILL: You may switch to ELINESTTM on any day from a progestin-only pill and should start taking the first pale pink ELINESTTM pill (“active” with hormone) the day after you take your last progestin-only pill. In addition, use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking.
If you are switching from a contraceptive vaginal ring or transdermal patch: Start taking the first pale pink ELINESTTM pill (“active” with hormone) on the day that you would have inserted a new ring or applied a new patch.
If you are switching from a contraceptive implant: Start taking the first pale pink ELINESTTM pill (“active” with hormone) on the day that the implant is removed.
If you are switching from a contraceptive injection: Start taking the first pale pink ELINESTTM pill (“active” with hormone) on the day that the next contraceptive injection is due.
If you are switching from an Intrauterine device (IUD) or Intrauterine system (IUS): Start taking the first pale pink ELINESTTM pill (“active” with hormone) on the day the IUD/IUS is removed. If your IUD/IUS is removed on the first day of your period you do not need to use an additional non-hormonal back up method of birth control. If the IUD/IUS is removed on any other day, use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking.
WHAT TO DO IF YOU MISS PILLS
ELINESTTM may not be as effective if you miss pale pink “active” pills, and particularly if you miss the first few or the last few pale pink “active” pills in a pack.
If you MISS 1 pale pink “active” pill:
1.Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.2.You could become pregnant if you have sex in the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days.
If you MISS 2 pale pink “active” pills in a row in WEEK 1 OR WEEK 2 of your pack:
1.Take 2 pills on the day you remember and 2 pills the next day.2.Then take 1 pill a day until you finish the pack.3.You could become pregnant if you have sex in the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days.
If you MISS 2 pale pink“active” pills in a row in THE 3rd WEEK:
1.Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.2.You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.3.You could become pregnant if you have sex in the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days.
If you MISS 3 OR MORE pale pink “active” pills in a row (during the first 3 weeks):
1.Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.2.You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.3.You could become pregnant if you have sex in the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days.
If you forget any of the 7 white “reminder” pills in Week 4:
Throw away the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up non-hormonal birth control method if you start your next pack on time.
FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED
Use a back-up non-hormonal birth control method anytime you have sex.
Keep taking one pill each day until you can reach your healthcare provider.
To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC.Toll-free at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for: Northstar Rx LLC
Memphis TN 38141
Manufactured by: Novast Laboratories Ltd.
Nantong, China 226009
I0103 Rev. 01/2023 Rev. B
Add image transcription here...
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1305089 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Elinest 28 Day] | BPCK | 7 |
| 749786 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 7 |
| 1305089 | ELINEST 28 Day Pack | PSN | 7 |
| 749786 | eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 7 |
| 748797 | inert 1 MG Oral Tablet | PSN | 7 |
| 311359 | norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 7 |
| 311359 | ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet | SCD | 7 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 7 |
| 1305089 | Elinest 28 Day Pack | SY | 7 |
| 311359 | ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral Tablet | SY | 7 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ETHINYL ESTRADIOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16714-365-01 | Elinest | 1 in 1 BLISTER PACK | KIT | 1 | 7 | |
| 16714-365-01 | Elinest | 1 in 1 PACKET | KIT | 1 | 7 | |
| 16714-365-02 | Elinest | 1 in 1 CARTON | KIT | 1 | 7 | |
| 16714-365-02 | Elinest | 1 in 1 BLISTER PACK | KIT | 1 | 7 | |
| 16714-365-03 | Elinest | 1 in 1 BLISTER PACK | KIT | 1 | 7 | |
| 16714-365-03 | Elinest | 3 in 1 CARTON | KIT | 3 | 7 | |
| 16714-365-04 | Elinest | 6 in 1 CARTON | KIT | 6 | 7 | |
| 16714-365-04 | Elinest | 1 in 1 BLISTER PACK | KIT | 1 | 7 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-365-01 | EA - Each | 16714-365 | f0b3fcaa-2546-4c5b-84ea-f04c5c890109 | 1 | 2013-05-02 |
| 16714-365-04 | EA - Each | 16714-365 | cd65ba93-fd85-4913-90d4-0e2399e04144 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | 2 | |
| Norgestrel | ACTIVE INGREDIENT | 3J8Q1747Z2 | 2 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | 2 | |
| Norgestrel | ACTIVE MOIETY | 3J8Q1747Z2 | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 2 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | 2 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 16714-365 | 16714-365-01, 16714-365-02, 16714-365-03, 16714-365-04 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TRIACETIN | TRIACETIN | XHX3C3X673 | CONCENTRATE / ORAL | 250 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | AEROSOL, FOAM / VAGINAL | 0.5 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SYRUP / ORAL | 4 mg/5ml | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION / TOPICAL | 1.4 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, ORALLY DISINTEGRATING / ORAL | 0.16 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, DELAYED RELEASE / ORAL | 23 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | POWDER / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | SYSTEM / TRANSDERMAL | 22.1 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | CAPSULE, EXTENDED RELEASE / ORAL | 98 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | POWDER, FOR SUSPENSION / ORAL | 12 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / INTRAMUSCULAR | 87 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | CAPSULE, EXTENDED RELEASE / ORAL | 51 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | CONCENTRATE / ORAL | 250 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, ORALLY DISINTEGRATING / ORAL | 0.16 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SYSTEM / TOPICAL | 420 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / SUBCUTANEOUS | 2.88 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | POWDER / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091105-001 | ELINEST | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 |
| Application-product | TE code |
|---|---|
| A091105-001 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A091105-001 | ELINEST | 0.03MG;0.3MG | TABLET / ORAL-28 | AB | 2012-03-28 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091105-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091105-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091105-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091105-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091105-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091105-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091105-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091105-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091105-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091105-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091105-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091105-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091105-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091105-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091105-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091105-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091105-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091105-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091105-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091105-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091105-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091105-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091105-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091105-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091105-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091105-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091105-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091105-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091105-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091105-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091105-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091105-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091105-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091105-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091105-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091105-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091105-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091105-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091105-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091105-001 | AB | 1 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Elinest | NORGESTREL AND ETHINYL ESTRADIOL | Northstar Rx LLC | aa7f4a83-71cf-4306-b0a1-01784f67bae2 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 16714-365-01 16714-365-04 16714-365-02 16714-365-03 16714-365 16714036503 16714036504 16714036502 16714036501 cf47f8b4-e64e-4128-a197-54bcce596aa1 aa7f4a83-71cf-4306-b0a1-01784f67bae2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.