1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percenta...
To achieve maximum contraceptive effectiveness, Jencycla must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.
Rx Only
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Jencycla™ Tablets
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C yellow No. 10, FD&C blue No. 1, lactose anhydrous, magnesium stearate, povidone and sodium starch glycolate.
The chemical name of norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. It has a molecular formula of C20H26O2 and a molecular weight of 298.4. It has the following structural formula:
Jencycla meets USP Dissolution Test 2.
1. Mode of Action
Jencycla progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
2. Pharmacokinetics
Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.
1. Indications
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy
If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.
| |||
| |||
| |||
| |||
| % of Women Experiencing an Unintended Pregnancy within the First Year of Use | % of Women Continuing Use at One Year* | ||
| Method | Typical Use †
| Perfect Use‡
| |
| (1) | (2) | (3) | (4) |
| No method§
| 85 | 85 | |
| Spermicides¶
| 28 | 18 | 42 |
| Fertility awareness-based methods | 24 | 47 | |
| Standard Days method#
TwoDay method# | 5 4 | ||
| Ovulation method#
| 3 | ||
| Symptothermal method#
| 0.4 | ||
| Withdrawal | 22 | 4 | 46 |
| Sponge | 36 | ||
| Parous women | 24 | 20 | |
| Nulliparous women | 12 | 9 | |
| Condom♠
| |||
| Female (fc) | 21 | 5 | 41 |
| Male | 18 | 2 | 43 |
| Diaphragm♥
| 12 | 6 | 57 |
| Combined pill and progestin-only pill | 9 | 0.3 | 67 |
| Norelgestromin and ethinyl estradiol patch | 9 | 0.3 | 67 |
| NuvaRing | 9 | 0.3 | 67 |
| Depo-Provera | 6 | 0.2 | 56 |
| Intrauterine contraceptives ParaGard (copper T) Mirena(LNg) | 0.8 0.2 | 0.6 0.2 | 78 80 |
| Implanon | 0.05 | 0.05 | 84 |
| Female sterilization | 0.5 | 0.5 | 100 |
| Male sterilization | 0.15 | 0.10 | 100 |
* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.
† Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and Depo-Provera are taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; see the text for the derivation of estimates for the other methods.
‡ Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. See the text for the derivation of the estimate for each method.
§ The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
¶ Foams, creams, gels, vaginal suppositories, and vaginal film.
# The Ovulation and Two Day methods are based on evaluation of cervical mucus. The Standard Days method avoids intercourse on cycle days 8 through 19. The Symptothermal method is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day.
♠ Without spermicides.
♥ With spermicidal cream or jelly.
Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.
Jencycla does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
1. Ectopic Pregnancy
The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.
2. Delayed Follicular Atresia/Ovarian Cysts
If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.
3. Irregular Genital Bleeding
Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.
4. Carcinoma of the Breast and Reproductive Organs
Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increases the risk.
A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years.
This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.
Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.
5. Hepatic Neoplasia
Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.
1. General
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. Physical Examination and Follow-up
It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.
3. Carbohydrate and Lipid Metabolism
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL3 , LDL, or VLDL.
4. Drug Interactions
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Substances decreasing the systemic concentrations of hormonal contraceptives (HCs) and potentially diminishing the efficacy of HCs:
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the systemic concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding.
Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Substances increasing the systemic concentrations of HCs:
Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the systemic concentrations of progestins, including norethindrone.
Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and nonnucleoside reverse transcriptase inhibitors:
Significant decreases in systemic concentrations of progestin have been noted in cases of co- administration with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine, efavirenz).
In contrast, significant increases in systemic exposure of the progestin have been noted in cases of co-administration with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).
These changes may be clinically relevant in some cases.
Consult the prescribing information of anti-viral and anti-retroviral concomitant medications to identify potential interactions.
Hormonal contraceptives may affect the metabolism of other drugs. Consequently, systemic concentrations may either increase (for example, cyclosporine) or decrease. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing. Therefore, if a woman wishes to use Jencycla after using ulipristal acetate, she should do so no sooner than 5 days after the intake of ulipristal acetate and she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period.
5. Interactions with Laboratory Tests
The following endocrine tests may be affected by progestin-only oral contraceptive use:
6. Carcinogenesis
See WARNINGS .
7. Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
8. Nursing Mothers
In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.
9. Pediatric Use
Safety and efficacy of Jencycla tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
10. Fertility Following Discontinuation
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.
11. Headache
The onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause.
1. See "Detailed Patient Labeling " for detailed information.
2. Counseling issues
The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:
Adverse reactions reported with the use of POPs include:
The following adverse reactions were also reported in clinical trials or during post-marketing experience:
Gastrointestinal Disorders
Vomiting, abdominal pain
General Disorders and Administration Site Conditions
Fatigue, edema
Psychiatric Disorders
Depression, nervousness
Musculoskeletal and Connective Tissue Disorders
Pain in extremity
Reproductive System and Breast Disorders
Genital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is stopped
Immune System Disorders
Anaphylactic/anaphylactoid reaction, hypersensitivity
Hepatobiliary Disorders
Hepatitis, jaundice cholestatic
Skin and Subcutaneous Tissue Disorders
Alopecia, rash, rash pruritic.
There have been no reports of serious ill effects from overdosage, including ingestion by children.
To achieve maximum contraceptive effectiveness, Jencycla must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.
Jencycla Tablets containing 0.35 mg of norethindrone, green colored, round, flat face, beveled edge tablets, debossed with "O23" on one side and "LU" on the other side.
Jencycla Tablets are available in a blister (NDC 68180-877-71) containing 28 tablets. Such three blisters are packaged in a carton (NDC 68180-877-73).
STORAGE: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep out of reach of children.
1. McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994.
2. Van Giersbergen PLM, Halabi A, Dingemanse J. Pharmacokinetic interaction between bosentan and the oral contraceptives norethisterone and ethinyl estradiol. Int J Clin Pharmacol Ther 2006;44(3):113-118.
3. Truitt ST, Fraser A, Gallo ME, Lopez LM, Grimes DA and Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation (Review). The Cochrane Collaboration. 2007, Issue 3.
4. Halderman, LD and Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns. Am J Obstet Gynecol.; 186 (6):1250-1258.
5. Ostrea EM, Mantaring III JB, Silvestre MA. Drugs that affect the fetus and newborn infant via the placenta or breast milk. Pediatr Clin N Am; 51(2004): 539-579.
6. Cooke ID, Back DJ, Shroff NE: Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diactetate administration. Contraception 1985; 31:611-21.
7. 2008 USPC Official:12/1/08-4/30/09, USP Monographs: Norethindrone Tablets (page 1 of 5).
Jencycla™ is a trademark of Lupin Pharmaceuticals, Inc.
The other brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.
Distributed by:
Lupin Pharmaceuticals, Inc.
Naples, FL 34108
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) - 454 775
INDIA
Revised: September 2024
DETAILED PATIENT LABELING
Jencycla™
(norethindrone tablets USP, 0.35 mg)
Rx Only
This product (like all oral contraceptives) is used to prevent pregnancy. It does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Jencycla™ Tablets
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C yellow No. 10, FD&C blue No. 1, lactose anhydrous, magnesium stearate, povidone and sodium starch glycolate.
The chemical name of norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. It has a molecular formula of C20H26O2 and a molecular weight of 298.4. It has the following structural formula:
Jencycla meets USP Dissolution Test 2.
This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your healthcare professional.
Progestin-only pills are often called "POPs" or "the minipill." POPs have less progestin than the combined birth control pill (or "the pill") which contains both an estrogen and a progestin.
About 1 in 200 POP users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 "typical" POP users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. Table 2 will help you compare the efficacy of different methods.
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| |||
| |||
| |||
| % of Women Experiencing an Unintended Pregnancy within the First Year of Use | % of Women Continuing Use at One Year* | ||
| Method | Typical Use †
| Perfect Use‡
| |
| (1) | (2) | (3) | (4) |
| No method§
| 85 | 85 | |
| Spermicides¶
| 28 | 18 | 42 |
| Fertility,awareness-based methods | 24 | 47 | |
| Standard Days method#
TwoDay method# | 5 4 | ||
| Ovulation method#
| 3 | ||
| Symptothermal method#
| 0.4 | ||
| Withdrawal | 22 | 4 | 46 |
| Sponge | 36 | ||
| Parous women | 24 | 20 | |
| Nulliparous women | 12 | 9 | |
| Condom♠
| |||
| Female (fc) | 21 | 5 | 41 |
| Male | 18 | 2 | 43 |
| Diaphragm♥
| 12 | 6 | 57 |
| Combined pill and progestin-only pill | 9 | 0.3 | 67 |
| Norelgestromin and ethinyl estradiol patch | 9 | 0.3 | 67 |
| NuvaRing | 9 | 0.3 | 67 |
| Depo-Provera | 6 | 0.2 | 56 |
| Intrauterine contraceptives ParaGard (copper T) Mirena(LNg) | 0.8 0.2 | 0.6 0.2 | 78 80 |
| Implanon | 0.05 | 0.05 | 84 |
| Female sterilization | 0.5 | 0.5 | 100 |
| Male sterilization | 0.15 | 0.10 | 100 |
* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.
† Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and Depo-Provera are taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; see the text for the derivation of estimates for the other methods.
‡ Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. See the text for the derivation of the estimate for each method.
§ The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
¶ Foams, creams, gels, vaginal suppositories, and vaginal film.
# The Ovulation and Two Day methods are based on evaluation of cervical mucus. The Standard Days method avoids intercourse on cycle days 8 through 19. The Symptothermal method is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day.
♠ Without spermicides.
♥ With spermicidal cream or jelly.
Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.
HOW DO POPs WORK?
POPs can prevent pregnancy in different ways including:
YOU SHOULD NOT TAKE POPs
RISKS OF TAKING POPs
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
WARNING:
If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately.
Ectopic Pregnancy
An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.
Ovarian Cysts
These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.
Cancer of the Reproductive Organs and Breasts
Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk.
A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.
Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.
Liver Tumors
In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer among women who use combined oral contraceptives. However, liver cancers are rare. There is insufficient data to determine whether POPs increase the risk of liver tumors.
Diabetic Women
Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your healthcare professional may monitor you more closely under these conditions.
SEXUALLY TRANSMITTED DISEASES (STDs)
WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.
SIDE EFFECTS
Irregular Bleeding:
The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can result in some spotting or bleeding.
Other Side Effects:
Less common side effects include headaches, tender breasts, nausea, vomiting, dizziness, and fatigue. Depression, nervousness, leg pain, vaginal discharge, fluid retention, allergic reactions, jaundice or a yellowing of the skin or eyeballs, loss of scalp hair, rash/itchy rash, weight gain, acne and extra hair on your face and body have been reported, but are rare.
If you are concerned about any of these side effects, check with your healthcare professional.
USING POPs WITH OTHER MEDICINES
Before taking a POP, inform your healthcare professional of any other medication, including over-the-counter medicine, that you may be taking.
These medicines can make POPs less effective:
Medicines for seizures such as:
Medicine for nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines:
Medicines for tuberculosis (TB):
Medicine for fungal infections such as:
Medicine for pulmonary hypertension such as:
Medicines used for the treatment of HIV infections or AIDS and infections due to Hepatitis C such as:
Herbal products such as:
These medicines and substances can increase your exposure to POPs:
Grapefruit juice
Medicines for fungal infections such as:
Before you begin taking any new medicines be sure your healthcare professional knows you are taking a progestin-only birth control pill.
HOW TO TAKE POPs
IMPORTANT POINTS TO REMEMBER
STARTING POPs
• Where on the pack to start taking pills,
• In what order to take the pills (follow the arrows), and
• The week numbers as shown in the picture below:
IF YOU ARE LATE OR MISS TAKING YOUR POPs
1) TAKE a missed pill as soon as you remember that you missed it,
2) THEN go back to taking POPs at your regular time,
3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
IF YOU ARE BREASTFEEDING
IF YOU ARE SWITCHING PILLS
PREGNANCY WHILE ON THE PILL
If you think you are pregnant, contact your healthcare professional. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don’t need when you are pregnant.
You should get a pregnancy test:
WILL POPs AFFECT YOUR ABILITY TO GET PREGNANT LATER?
If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant.
BREASTFEEDING
If you are breastfeeding, POPs will not affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported.
OVERDOSE
No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.
OTHER QUESTIONS OR CONCERNS
If you have any questions or concerns, check with your healthcare professional. You can also ask for the more detailed "Professional Labeling" written for doctors and other healthcare professionals.
HOW TO STORE YOUR POPs
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Keep out of reach of children.
Jencycla™ is a trademark of Lupin Pharmaceuticals, Inc.
The other brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.
Distributed by:
Lupin Pharmaceuticals, Inc.
Naples, FL 34108
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) - 454 775
INDIA
Revised: September 2024 ID#: 277626
Jencycla™
(norethindrone tablets USP)
0.35 mg
Carton Pack:
NDC: 68180-877-73
3 Blisters of 28 Tablets Each
Jencycla™
(norethindrone tablets USP)
0.35 mg
Blister Pack:
NDC: 68180-877-71
1 Blister of 28 Tablets
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1422896 | {28 (norethindrone 0.35 MG Oral Tablet) } Pack [Jencycla 28 Day] | BPCK | 6 |
| 748961 | {28 (norethindrone 0.35 MG Oral Tablet) } Pack | GPCK | 6 |
| 1422896 | Jencycla 28 Day Pack | PSN | 6 |
| 748961 | Noreth 0.35 MG (28) Oral Tablet 28 Day Pack | PSN | 6 |
| 198042 | norethindrone 0.35 MG Oral Tablet | PSN | 6 |
| 198042 | norethindrone 0.35 MG Oral Tablet | SCD | 6 |
| 1422896 | Jencycla 28 Day Pack | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| NORETHINDRONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0368180877714 | GTIN-13: 0368180877714 EAN-13: 0368180877714 GTIN-12: 368180877714 UPC-A: 368180877714 GTIN storage (14 digits): 00368180877714 | 223eb6ba-f676-4483-9511-55ab00a1debc-07.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68180-877-73 | Jencycla | 1 in 1 CARTON | TABLET | 1 | 6 | |
| 68180-877-73 | Jencycla | 28 in 1 BLISTER PACK | TABLET | 28 | 6 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68180-877-11 | EA - Each | 68180-877 | 9fedc298-dc23-41c5-961e-550948b1c2be | 1 | 2013-06-04 |
| 68180-877-13 | EA - Each | 68180-877 | 5025bc0a-f3fa-4cfd-b856-15740bc42d12 | 1 | 2013-06-04 |
| 68180-877-71 | EA - Each | 68180-877 | 88edc585-1515-4208-879d-2c97bc1513dc | 1 | 2020-08-06 |
| 68180-877-73 | EA - Each | 68180-877 | d231dd5e-3f0f-497b-9206-c0be1eddd6d6 | 1 | 2020-08-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68180-877 | 68180-877-73 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NORETHINDRONE | T18F433X4S | ACTIB |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A091323-001 | JENCYCLA | NORETHINDRONE | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 |
| Application-product | TE code |
|---|---|
| A091323-001 | AB2 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091323-001 | JENCYCLA | 0.35MG | TABLET / ORAL-28 | AB2 | 2013-03-28 | 3a93d1ddd44b… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091323-001 | AB2 | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091323-001 | AB2 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091323-001 | AB2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091323-001 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091323-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091323-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091323-001 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091323-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091323-001 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091323-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091323-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091323-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091323-001 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091323-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091323-001 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091323-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091323-001 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091323-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091323-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091323-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091323-001 | AB2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091323-001 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091323-001 | AB2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091323-001 | AB2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091323-001 | AB2 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091323-001 | AB2 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091323-001 | AB2 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091323-001 | AB2 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091323-001 | AB2 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091323-001 | AB2 | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091323-001 | AB2 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091323-001 | AB2 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091323-001 | AB2 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091323-001 | AB2 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091323-001 | AB2 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091323-001 | AB2 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091323-001 | AB2 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091323-001 | AB2 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091323-001 | AB2 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091323-001 | AB2 | 1 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Jencycla | NORETHINDRONE | Lupin Pharmaceuticals, Inc. | e91e7bdd-2984-4332-9b0b-04322792d7f6 | 2025-12-08 | Warnings, Adverse reactions | 68180-877-73 68180-877 68180087773 223eb6ba-f676-4483-9511-55ab00a1debc e91e7bdd-2984-4332-9b0b-04322792d7f6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.