NDC Code(s) : 0378-7277-85, 0378-7277-53
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NORGESTIMATE AND ETHINYL ESTRADIOLnorgestimate and ethinyl estradiol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7277
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7277-533 in 1 CARTON 31/12/2015
1NDC:0378-7277-851 in 1 POUCH
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202132 12/31/2015

PRINCIPAL DISPLAY PANEL

NDC 0378-7277-53

Rx only

Norgestimate and Ethinyl

Estradiol Tablets, USP

0.18 mg/0.025 mg

0.215 mg/0.025 mg

0.25 mg/0.025 mg

7 white to off-white tablets each containing 0.18 mg norgestimate and 0.025 mg ethinyl estradiol.

7 light yellow tablets each containing 0.215 mg norgestimate and 0.025 mg ethinyl. estradiol.

7 yellow tablets each containing 0.25 mg norgestimate and 0.025 mg ethinyl estradiol.

7 green tablets each containing inert ingredients.

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

3 pouches, each pouch contains one blister pack of 28 tablets

Norgestimate and Ethinyl Estradiol Tablets, USP Carton Label