7 Ethinyl Estradiol 0.025 MG norgestimate 0.18 MG Oral Tablet 7 Ethinyl Estradiol 0.025 MG norgestimate 0.215 MG Oral Tablet 7 Ethinyl Estradiol 0.025 MG norgestimate 0.25 MG Oral Tablet 7 Inert Ingredients 1 MG Oral Tablet Pack
1 INDICATIONS AND USAGE Norgestimate and ethinyl estradiol tablets are an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Norgestimate and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )].
glenmark pharmaceuticals inc., usa
ROUND GREEN C9
C9 ROUND GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Norgestimate and Ethinyl Estradiol Tablets USP are available as blister card pill dispensers (NDC 68462-719-84). Each blister card contains 28 tablets in the following order: • 7 white to off-white, round, biconvex, film coated tablets (active), debossed with ‘C8’ on one side. Each tablet contains 0.18 mg norgestimate, USP and 0.025 mg ethinyl estradiol, USP. • 7 light blue, round, biconvex, film coated tablets (active), debossed with ‘C7’ on one side. Each tablet contains 0.215 mg norgestimate, USP and 0.025 mg ethinyl estradiol, USP. • 7 blue, round, biconvex, film coated tablets (active), debossed with ‘C6’ on one side. Each tablet contains 0.25 mg norgestimate, USP and 0.025 mg ethinyl estradiol, USP. • 7 green to dark green, round, biconvex, film coated tablets (non-hormonal placebo), debossed with ‘C9’ on one side. Each tablet contains inert ingredients. NDC 68462-719-29 1 carton containing 3 blister cards of 28 tablets 16.2 Storage Conditions • Store at 20 to 25°C (68 to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] • Keep out of reach of children.
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