NDC Code(s) : 68180-838-71, 68180-838-73
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Norgestimate and ethinyl estradiol Norgestimate and ethinyl estradiol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-838
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-838-733 in 1 CARTON 08/08/2019
1NDC:68180-838-711 in 1 CARTON Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205588 08/08/2019

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 650582310 MANUFACTURE(68180-838), PACK(68180-838)

PRINCIPAL DISPLAY PANEL

Carton Label

NDC 68180-838-73

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

Blister pack containing 28 tablets packed in a Pouch. Such three Pouches are packaged in a Carton.

Rx only

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. THIS PACKAGE IS NOT CHILD RESISTANT.

Pharmacist: Each unit contains information intended for the patients. This informational piece is to be provided to the patient with each prescription.

carton

Pouch Label

NDC 68180-838-71

Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035

Blister pack containing 28 tablets packed in a Pouch.

Rx only

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. THIS PACKAGE IS NOT CHILD RESISTANT.

Pharmacist: Each unit contains information intended for the patients. This informational piece is to be provided to the patient with each prescription.

carton

Blister Label

NDC 68180-838-71

Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035

28 Tablets

Rx only

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. THIS PACKAGE IS NOT CHILD RESISTANT.

Pharmacist: Each unit contains information intended for the patients. This informational piece is to be provided to the patient with each prescription.

carton