NDC Code(s) : 75834-255-90, 75834-255-01, 75834-255-05, 75834-255-50, 75834-256-90, 75834-256-01, 75834-256-05, 75834-256-50, 75834-257-90, 75834-257-50, 75834-257-25, 75834-257-01, 75834-258-90, 75834-258-50, 75834-258-02, 75834-258-01
Packager : NIVAGEN PHARMACEUTICALS, INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atorvastatin calciumAtorvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-255
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN(UNII: A0JWA85V8F)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM CARBONATE(UNII: H0G9379FGK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code ATO;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75834-255-9090 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
2NDC:75834-255-011000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
3NDC:75834-255-055000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
4NDC:75834-255-50500 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213853 08/26/2020
Atorvastatin calciumAtorvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-256
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN(UNII: A0JWA85V8F)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code ATO;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75834-256-9090 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
2NDC:75834-256-011000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
3NDC:75834-256-055000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
4NDC:75834-256-50500 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213853 08/26/2020
Atorvastatin calciumAtorvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-257
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN(UNII: A0JWA85V8F)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM CARBONATE(UNII: H0G9379FGK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code ATO;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75834-257-9090 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
2NDC:75834-257-50500 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
3NDC:75834-257-252500 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
4NDC:75834-257-011000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213853 08/26/2020
Atorvastatin calciumAtorvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-258
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN(UNII: A0JWA85V8F)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM CARBONATE(UNII: H0G9379FGK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code ATO;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75834-258-9090 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
2NDC:75834-258-50500 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
3NDC:75834-258-022000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
4NDC:75834-258-011000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213853 08/26/2020

LABELER - NIVAGEN PHARMACEUTICALS, INC.(052032418)

Establishment
Name Address ID/FEI Business Operations
UMEDICA LABORATORIES PRIVATE LIMITED 920635096 analysis(75834-255, 75834-256, 75834-257, 75834-258), manufacture(75834-255, 75834-256, 75834-257, 75834-258)

PRINCIPAL DISPLAY PANEL

Atorvastatin Calcium Tablets, USP 10 mg NDC 75834-255-90 - 90s Bottle Label
atorvastatin-calcium-10-90

Atorvastatin Calcium Tablets, USP 20 mg NDC 75834-256-01 - 1000s Bottle Label

atorvastatin-calcium-10-90

Atorvastatin Calcium Tablets, USP 40 mg NDC 75834-257-50 - 500s Bottle Label
atorvastatin-calcium-10-90

Atorvastatin Calcium Tablets, USP 80 mg NDC 75834-258-02 - 2000s Bottle Label
atorvastatin-calcium-10-90