NDC Code(s) : 68462-720-84, 68462-720-29
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

drospirenone and ethinyl estradioldrospirenone and ethinyl estradiol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-720
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K25(UNII: K0KQV10C35)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-720-293 in 1 CARTON 17/08/2015
1NDC:68462-720-841 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 ANDA204296 08/17/2015

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS(68462-720), MANUFACTURE(68462-720)

PRINCIPAL DISPLAY PANEL

NDC 68462-720-29
Drospirenone and Ethinyl Estradiol Tablets, USP
3 mg/0.02 mg

carton