Norgestimate and Ethinyl Estradiol

Contraindications ( 4 ) 08/2017 Warnings and Precautions ( 5.3 ) 08/2017

1 INDICATIONS AND USAGE Norgestimate and Ethinyl Estradiol Tablets USP are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1) Norgestimate and Ethinyl Estradiol Tablets USP is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and Ethinyl Estradiol Tablets USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2) 1.1 Oral Contraceptive Norgestimate and ethinyl estradiol tablets USP are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14 )]. 1.2 Acne Norgestimate and ethinyl estradiol tablets USP are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES ( 14 )].

1.2 Acne Norgestimate and ethinyl estradiol tablets USP are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES ( 14 )].

2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day. ( 2.1) • Take tablets in the order directed on the blister pack. (2.1) • Do not skip or delay tablet intake. ( 2.1) 2.1 Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Norgestimate and Ethinyl Estradiol Tablets USP. Table 1: Instructions for Administration of Norgestimate and Ethinyl Estradiol Tablets USP Starting COCs in women not currently using hormonal contraception ( Day 1 Start or Sunday Start ) Important : Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color : • Norgestimate and ethinyl estradiol tablets USP active tablets are light blue (Day 1 to Day 7), medium blue (Day 8 to Day 14) and dark blue (Day 15 to Day 21). • Norgestimate and ethinyl estradiol tablets USP both have white inactive tablets (Day 22 to Day 28). Day 1 Start : • Take first active tablet without regard to meals on the first day of menses. • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one white inactive tablet daily for 7 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start : • Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant , use additional non - hormonal contraception ( such as condoms and spermicide ) for the first seven days of the patient’s first cycle pack of norgestimate and ethinyl estradiol tablets USP . • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one white inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to norgestimate and ethinyl estradiol tablets USP from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to norgestimate and ethinyl estradiol tablets USP Start norgestimate and ethinyl estradiol tablets USP : • Transdermal patch • On the day when next application would have been scheduled • Vaginal ring • On the day when next insertion would have been scheduled • Injection • On the day when next injection would have been scheduled • Intrauterine contraceptive • On the day of removal If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. • Implant • On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA - Approved Patient Labeling . Starting Norgestimate and Ethinyl Estradiol Tablets USP after Abortion or Miscarriage First-trimester: • After a first-trimester abortion or miscarriage, norgestimate and ethinyl estradiol tablets USP may be started immediately. An additional method of contraception is not needed if norgestimate and ethinyl estradiol tablets USP is started immediately. • If norgestimate and ethinyl estradiol tablets USP is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of norgestimate and ethinyl estradiol tablets USP. Second-trimester: • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboemb …

3 DOSAGE FORMS AND STRENGTHS Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, in the following order: • 21 blue, round, flat faced beveled edged, uncoated tablets, debossed with ‘A7’ on one side and plain on the other. Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. • 7 light green, round, flat faced beveled edged, uncoated tablets debossed with ‘A2’on one side and plain on the other. Each light green tablet contains inert ingredients. Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are available in blister cards. Each blister card contains 28 tablets in the following order: • 7 white to off-white, round, flat faced beveled edge, uncoated tablets, debossed with ‘A9’ on one side and plain on the other. Each white to off-white tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. • 7 light blue, round, flat faced beveled edge, uncoated tablets, debossed with ‘A8’ on one side and plain on the other. Each light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. • 7 blue, round, flat faced beveled edge, uncoated tablets, debossed with ‘A7’ on one side, and plain on the other. Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. • 7 light green, round, flat faced beveled edge, uncoated tablets, debossed with ‘A2’ on one side and plain on the other. Each light green tablet contains inert ingredients. Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg, consist of 28 round, flat faced beveled edged, uncoated tablets in the following order ( 3 ): • 21 blue tablets each containing 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP • 7 light green tablets (inert) Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, consist of 28 round, flat faced beveled edged, uncoated tablets in the following order ( 3 ): • 7 white to off-white tablets each containing 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP • 7 light blue tablets each containing 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP • 7 blue tablets each containing 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP • 7 light green tablets (inert)

4 CONTRAINDICATIONS Norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see BOXED WARNING AND WARNINGS AND PRECAUTIONS ( 5.1 )] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have coronary artery disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS ( 5.4 )] o Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS ( 5.6 )] o Have headaches with focal neurological symptoms or migraine headaches with aura [see WARNINGS AND PRECAUTIONS ( 5.7 )] ■ Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS ( 5.7 )] • Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS ( 5.2 )] • Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS ( 5.8 )] • Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS ( 5.9 ) AND USE IN SPECIFIC POPULATIONS ( 8.1 )] • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see WARNINGS AND PRECAUTIONS ( 5.11 )] • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions ( 5.3 )] • A high risk of arterial or venous thrombotic diseases ( 4 ) • Liver tumors or liver disease ( 4 ) • Undiagnosed abnormal uterine bleeding ( 4 ) • Pregnancy( 4 ) • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive ( 4 ) • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )

6 ADVERSE REACTIONS The most common adverse reactions reported during clinical trials (≥2%) were: Norgestimate and ethinyl estradiol tablets: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling: • Serious cardiovascular events and stroke [see BOXED WARNING AND WARNINGS AND PRECAUTIONS ( 5.1 )] • Vascular events [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Liver disease [see WARNINGS AND PRECAUTIONS ( 5.2 )] 6.1 Clinical Trial 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. Norgestimate and Ethinyl Estradiol Tablets USP (0.250 mg/0.035 mg) The safety of Norgestimate and Ethinyl Estradiol Tablets USP (0.250 mg/0.035 mg) was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of Norgestimate and Ethinyl Estradiol Tablets USP (0.250 mg/0.035 mg) for contraception. Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. In all 3 trials, subjects were followed for up to 24 cycles. Common Adverse Reactions (≥ 2% of subjects): The most common adverse reactions reported by at least 2% of the 1,647 women were the following in order of decreasing incidence: headache/migraine (32.9%), abdominal/gastrointestinal pain (7.8%), vaginal infection (8.4%), genital discharge (6.8%), breast issues (including breast pain, discharge, and enlargement) (6.3%), mood disorders (including depression and mood altered) (5.0%), flatulence (3.2%), nervousness (2.9%), and rash (2.6%). Adverse Reactions Leading to Study Discontinuation: Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions (≥1%) leading to discontinuation were: metrorrhagia (6.9%), nausea/vomiting (5.0%), headache (4.1%), mood disorders (including depression and mood altered) (2.4%), premenstrual syndrome (1.7%), hypertension (1.4%), breast pain (1.4%), nervousness (1.3%), amenorrhea (1.1%), dysmenorrhea (1.1%), weight increased (1.1%), and flatulence (1.1%). Serious Adverse Reactions : breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject). Norgestimate and Ethinyl Estradiol Tablets USP The safety of Norgestimate and Ethinyl Estradiol Tablets USP was evaluated in 4,826 healthy women of child-bearing potential who participated in 6 clinical trials and received at least 1 dose of Norgestimate and Ethinyl Estradiol Tablets USP for contraception. Two trials were randomized active-controlled trials and 4 were uncontrolled open-label trials. In 3 trials, subjects were followed for up to 24 cycles; in 2 trials, subjects were followed for up to 12 cycles; and in 1 trial, subjects were followed for up to 6 cycles. Common Adverse Reactions (≥ 2% of subjects): The most common adverse reactions reported by at least 2% of the 4,826 women were the following in order of decreasing incidence: headache/migraine (33.6%), breast issues (including breast pain, enlargement, and discharge) (8.0%), vaginal infection (7.1%), abdominal/gastrointestinal pain (5.6%), mood disorders (including mood alteration and depression) (3.8%), genital discharge (3.2%), and changes in weight ( …

7 DRUG INTERACTIONS Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. ( 7.1 ) Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. No drug-drug interaction studies were conducted with norgestimate and ethinyl estradiol tablets. 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations 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 ethinyl estradiol (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. CYP3A4 inhibitors such as itraconazole, voriconazole, 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 , and HIV/AIDS medications containing strong inhibitors or inducers of CYP3A Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with 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., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]) or with HIV/AIDS medications containing strong inhibitors (e.g., cobicistat and ritonavir) or inducers of CYP3A 7.2 Effects of Combined Oral Contraceptives on Other Drugs • COCs containing EE may inhibit the metabolism of other compounds (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 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 the serum concentration of thyroid-binding globulin increases with use of COCs. 7.3 Interference with Laboratory Tests …

8 USE IN SPECIFIC POPULATIONS Lactating women: Not recommended; can decrease milk production.. (8.2) 8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy, therefore, Norgestimate and Ethinyl Estradiol Tablets USP should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. 8.2 Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other forms of contraception until she discontinues breast-feeding. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Norgestimate and Ethinyl Estradiol Tablets USP and any potential adverse effects on the breast-fed child from Norgestimate and Ethinyl Estradiol Tablets USP or from the underlying maternal condition. 8.4 Pediatric Use Safety and efficacy of norgestimate 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 18 and for users 18 years and older. Use of this product before menarche is not indicated. There was no significant difference between norgestimate and ethinyl estradiol tablets and placebo in mean change in total lumbar spine (L1 to L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population. 8.5 Geriatric Use Norgestimate and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. 8.6 Hepatic Impairment The pharmacokinetics of norgestimate and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. 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. [see CONTRAINDICATIONS ( 4 ) AND WARNINGS AND PRECAUTIONS ( 5.2 ).] 8.7 Renal Impairment The pharmacokinetics of norgestimate and ethinyl estradiol tablets has not been studied in women with renal impairment.

8.6 Hepatic Impairment The pharmacokinetics of norgestimate and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. 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. [see CONTRAINDICATIONS ( 4 ) AND WARNINGS AND PRECAUTIONS ( 5.2 ).]

12.1 Mechanism of Action • Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. • Acne Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production. While the combination of ethinyl estradiol and norgestimate increases sex hormone-binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established.

11 DESCRIPTION Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg • Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, FD&C Blue No. 2, colloidal silicon dioxide, talc, magnesium stearate, and pregelatinized starch. • Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg • Each white to off-white tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, magnesium stearate, colloidal silicon dioxide, talc and pregelatinized starch. • Each light blue tablet contains 0.215 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include FD & C Blue No. 2, lactose monohydrate, povidone, magnesium stearate, colloidal silicon dioxide, talc and pregelatinized starch. • Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include FD & C Blue No. 2, lactose monohydrate, povidone, magnesium stearate, colloidal silicon dioxide, talc and pregelatinized starch. • Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. chem-structures

10 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.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) are available in a blister card (NDC 79929-009-05). Each blister (28 tablets) contains in the following order: • 7 light blue unscored round tablets debossed on one side with “12”; the tablet contains 0.18 mg norgestimate and 0.035 mg ethinyl estradiol • 7 medium blue unscored round tablets debossed on one side with “13”; the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol • 7 dark blue unscored round tablet debossed on one side with “14”; the tablet contains 0.25 mg norgestimate and 0.035 mg ethinyl estradiol • 7 white unscored round tablets (non-hormonal placebo) debossed on one side with “11”; the tablet contains inert ingredients Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) are packaged in a carton containing 3 blister cards. VERIDATE Tablet Dispenser is not applicable for the ANDA product. 16.2 Storage Conditions Store at 20–25°C (68–77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Keep out of the reach of children.

16.1 How Supplied Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) are available in a blister card (NDC 79929-009-05). Each blister (28 tablets) contains in the following order: • 7 light blue unscored round tablets debossed on one side with “12”; the tablet contains 0.18 mg norgestimate and 0.035 mg ethinyl estradiol • 7 medium blue unscored round tablets debossed on one side with “13”; the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol • 7 dark blue unscored round tablet debossed on one side with “14”; the tablet contains 0.25 mg norgestimate and 0.035 mg ethinyl estradiol • 7 white unscored round tablets (non-hormonal placebo) debossed on one side with “11”; the tablet contains inert ingredients Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) are packaged in a carton containing 3 blister cards. VERIDATE Tablet Dispenser is not applicable for the ANDA product.

16.2 Storage Conditions Store at 20–25°C (68–77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Keep out of the reach of children.