Next Choice TM is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later. Next Choice TM is available only by prescription for women younger than age ...
Take one levonorgestrel tablet orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Next Choice TM can be used at any time during the menstrual cycle. If vomiting occurs within two hours of ta...
Next Choice TM (levonorgestrel) tablets, 0.75 mg, are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced and embossed with “475” on one side and “WATSON” on the other side. Available as: Unit-of-use NDC 52544-275-36 Store Next Choice TM tablets at 20° to 25°C (68° to 77°F) [see USP controlled room temperature].
www.fda.gov/medwatch
www.mynextchoice.comNext ChoiceTM is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later.
Next ChoiceTM is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.
Next ChoiceTM is not indicated for routine use as a contraceptive.
Take one levonorgestrel tablet orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Next ChoiceTM can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking either dose of medication, consideration should be given to repeating the dose.
Each Next ChoiceTM tablet is supplied as a peach, round, bevel edged, flat faced tablet containing 0.75 mg of levonorgestrel and is embossed with “475” on one side and “WATSON” on the other side.
Next ChoiceTM is contraindicated for use in the case of known or suspected pregnancy.
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.
A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Next ChoiceTM. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Next ChoiceTM.
Next ChoiceTM is not effective in terminating an existing pregnancy.
Some women may experience spotting a few days after taking Next ChoiceTM. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception. If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.
Next ChoiceTM does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
A physical examination is not required prior to prescribing Next ChoiceTM. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Next ChoiceTM.
A rapid return of fertility is likely following treatment with Next ChoiceTM for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Next ChoiceTM to ensure ongoing prevention of pregnancy.
Next ChoiceTM contains FD&C Yellow #6 as a color additive.
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. A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of levonorgestrel tablets (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two tablets taken 12 hours later).
The most common adverse events (>10%) in the clinical trial for women receiving levonorgestrel tablets included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%). Table 1 lists those adverse events that were reported in >5% of levonorgestrel tablets users.
| Most Common Adverse Events | Levonorgestrel
N=977 (%) |
| Nausea | 23.1 |
| Abdominal Pain | 17.6 |
| Fatigue | 16.9 |
| Headache | 16.8 |
| Heavier Menstrual Bleeding | 13.8 |
| Lighter Menstrual Bleeding | 12.5 |
| Dizziness | 11.2 |
| Breast Tenderness | 10.7 |
| Other complaints | 9.7 |
| Vomiting | 5.6 |
| Diarrhea | 5.0 |
The following adverse reactions have been identified during post-approval use of Next ChoiceTM. 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.
Gastrointestinal Disorders
Abdominal Pain, Nausea, Vomiting
General Disorders and Administration Site Conditions
Fatigue
Nervous System Disorders
Dizziness, Headache
Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain
Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:
Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of coadministration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.
Many studies have found no harmful effects on fetal development associated with longterm use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.
In general, no adverse effects of progestin-only pills 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 taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.
Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older. Use of Next ChoiceTM emergency contraception before menarche is not indicated.
This product is not intended for use in postmenopausal women.
No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both levonorgestrel tablets and the Yuzpe regimen (another form of emergency contraception). The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.
No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets.
No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets.
Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Next ChoiceTM.
There are no data on overdosage of levonorgestrel tablets, although the common adverse event of nausea and associated vomiting may be anticipated.
Each Next ChoiceTM tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-1 7-hydroxy-, (17α)-(-)-], a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, corn starch, FD&C Yellow #6, magnesium stearate, povidone, and lactose monohydrate. Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:
Emergency contraceptive pills are not effective if a woman is already pregnant. Next ChoiceTM is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, they may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.
Absorption
No specific investigation of the absolute bioavailability of levonorgestrel tablets in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism.
After a single dose of levonorgestrel tablets (0.75 mg) administered to 16 women under fasting conditions, the mean maximum serum concentration of levonorgestrel was 14.1 ng/mL at an average of 1.6 hours. See Table 2.
| Mean (± SD) | ||||||
| Cmax | Tmax | CL | Vd | t1/2 | AUCinf | |
| (ng/mL) | (h) | (L/h) | (L) | (h) | (ng·hr/mL) | |
| Levonorgestrel | 14.1 (7.7) | 1.6 (0.7) | 7.7 (2.7) | 260.0 | 24.4 (5.3) | 123.1 (50.1) |
Cmax = maximum concentration
Tmax = time to maximum concentration
CL = clearance
Vd = volume of distribution
t1/2 = elimination half life
AUCinf = area under the drug concentration curve from time 0 to infinity
Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of levonorgestrel has not been evaluated.
Distribution
The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin.
Metabolism
Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16βhydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.
Excretion
About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.
Specific Populations
Pediatric: This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for this population.
Geriatric: This product is not intended for use in postmenopausal women and pharmacokinetic data are not available for this population.
Race: No formal studies have evaluated the effect of race on pharmacokinetics of levonorgestrel tablets. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both levonorgestrel tablets and the Yuzpe regimen (another form of emergency contraception). The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown [see USE IN SPECIFIC POPULATIONS (8.6) ].
Hepatic Impairment: No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets.
Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets.
Drug-Drug Interactions
No formal drug-drug interaction studies were conducted with levonorgestrel tablets [see DRUG INTERACTIONS (7) ].
Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 μg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 μg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. There were no malignancies.
Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay in mice.
Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general.
A double-blind, randomized, multinational controlled clinical trial in 1,955 evaluable women (mean age 27) compared the efficacy and safety of levonorgestrel tablets (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two additional tablets taken 12 hours later). After a single act of intercourse occurring anytime during the menstrual cycle, the expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with levonorgestrel tablets.
Emergency contraceptives are not as effective as routine hormonal contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE (1) ].
At the time of expected menses, approximately 74% of women using levonorgestrel tablets had vaginal bleeding similar to their normal menses, 14% bled more than usual, and 12% bled less than usual. The majority of women (87%) had their next menstrual period at the expected time or within + 7 days, while 13% had a delay of more than 7 days beyond the anticipated onset of menses.
Next ChoiceTM (levonorgestrel) tablets, 0.75 mg, are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced and embossed with “475” on one side and “WATSON” on the other side.
Available as: Unit-of-use NDC 52544-275-36
Store Next ChoiceTM tablets at 20° to 25°C (68° to 77°F) [see USP controlled room temperature].
Manufactured by: Watson Laboratories, Inc.
Corona, CA 92880 USA
Distributed by: Watson Pharma, Inc.
Corona, CA 92880 USA
Phone: 1 -866-9WATSON (1-866-992-8766)
Issued: August 2009
190229-1
0809B
Repacked by:
H.J. Harkins Company, Inc.
Grover Beach, CA 93433
Next Choice™
(Levonorgestrel) tablets 0.75 mg
Emergency Contraceptive
Reduces the chance of pregnancy after unprotected sex (if a regular birth control method fails or after sex without birth control).
Not for regular birth control.
Next Choice™ should be used only in emergencies.
2 Levonorgestrel Tablets
0.75 mg each
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 854861 | {2 (levonorgestrel 0.75 MG Oral Tablet) } Pack [Next Choice] | BPCK | 1 |
| 763088 | {2 (levonorgestrel 0.75 MG Oral Tablet) } Pack | GPCK | 1 |
| 763088 | Levonorgest 0.75 MG (2) Oral Tablet | PSN | 1 |
| 259218 | levonorgestrel 0.75 MG 2 Count Oral Tablet Pack | PSN | 1 |
| 854861 | Next Choice 0.75 MG Oral Tablet 2 Count Pack | PSN | 1 |
| 259218 | levonorgestrel 0.75 MG Oral Tablet | SCD | 1 |
| 854861 | Next Choice (levonorgestrel 0.75 MG) Pack | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| LEVONORGESTREL Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230718 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52959-450-02 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e561-cd31-e053-dbdaa90ab51a | These highlights do not include all the information needed to use Next Choice TM safely and effectively. See full prescribing information for Next Choice TM . Next Choice TM (levonorgestrel) Tablets, 0.75 mg, for oral use Initial U.S. Approval: 1982 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-450-02 | Next Choice | 2 in 1 BLISTER PACK | TABLET | 2 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-450-02 | EA - Each | 52959-450 | 87b7f57c-710e-4a08-8a1d-fa6feb00bc57 | 1 | 2013-02-13 |
| 52544-275-36 | EA - Each | 52544-275 | ff4d33c2-5010-4ecc-ba57-c52d627c25bb | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | 1 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52959-450 | 52959-450-02 |
| 52544-275 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LEVONORGESTREL | 5W7SIA7YZW | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
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 |
|---|---|---|---|---|---|---|
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | ELIXIR / ORAL | 5.4 mg/5ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / SUBLINGUAL | 505 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 9.5 %w/v | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / BUCCAL | 1 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 214 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 174 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, EXTENDED RELEASE / ORAL | 5364 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE / ORAL | 3990 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED / ORAL | 300 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 520 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INSERT / VAGINAL | 2282 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 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 |
|---|---|---|---|---|---|---|---|
| A078665-001 | LEVONORGESTREL | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 |
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 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078665-001 | LEVONORGESTREL | 0.75MG | TABLET / ORAL | 2009-08-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078665-001 | LEVONORGESTREL | 0.75MG | TABLET / ORAL | 2009-08-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 2009-08-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078665-001 | LEVONORGESTREL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2009-08-28 | 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 |
|---|---|---|---|---|---|---|
| 9d232871-21b7-423b-8c70-ed1bdd8901a0 | 5b1e51bd-4496-4f65-9f1d-40fb2ac5016c | 2012-10-29 | Warnings, Adverse reactions | 9d232871-21b7-423b-8c70-ed1bdd8901a0 5b1e51bd-4496-4f65-9f1d-40fb2ac5016c |
Adverse event summaries are temporarily unavailable. Other product information remains available.