NDC Code(s) : 50228-451-90, 50228-451-10, 50228-452-90, 50228-452-05, 50228-453-90, 50228-453-10, 50228-454-90, 50228-454-05
Packager : ScieGen Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ATORVASTATIN CALCIUMATORVASTATIN CALCIUM TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-451
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code SG;152
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-451-9090 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
2NDC:50228-451-101000 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205519 05/19/2016
ATORVASTATIN CALCIUMATORVASTATIN CALCIUM TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-452
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code SG;153
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-452-9090 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
2NDC:50228-452-05500 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205519 05/19/2016
ATORVASTATIN CALCIUMATORVASTATIN CALCIUM TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-453
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code SG;154
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-453-9090 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
2NDC:50228-453-101000 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205519 05/19/2016
ATORVASTATIN CALCIUMATORVASTATIN CALCIUM TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-454
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM CARBONATE(UNII: 45P3261C7T)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code SG;155
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50228-454-9090 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
2NDC:50228-454-05500 in 1 BOTTLE Type 0: Not a Combination Product19/05/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205519 05/19/2016

LABELER - ScieGen Pharmaceuticals, Inc.(079391286)

Establishment
Name Address ID/FEI Business Operations
ScieGen Pharmaceuticals, Inc. 079391286 manufacture(50228-451, 50228-452, 50228-453, 50228-454), analysis(50228-451, 50228-452, 50228-453, 50228-454)

PRINCIPAL DISPLAY PANEL

NDC 50228- 451-90

Atorvastatin Calcium

Tablets, USP

10 mg *

90 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab

NDC 50228- 451-10

Atorvastatin Calcium

Tablets, USP

10 mg *

1,000 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab

NDC 50228- 452-90

Atorvastatin Calcium

Tablets, USP

20 mg *

90 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab

NDC 50228- 452-05

Atorvastatin Calcium

Tablets, USP

20 mg *

500 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab

NDC 50228- 453-90

Atorvastatin Calcium

Tablets, USP

40 mg *

90 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab

NDC 50228- 453-10

Atorvastatin Calcium

Tablets, USP

40 mg *

1,000 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab

NDC 50228- 454-90

Atorvastatin Calcium

Tablets, USP

80 mg *

90 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab

NDC 50228- 454-05

Atorvastatin Calcium

Tablets, USP

80 mg *

500 Tablets Rx Only

ScieGen Pharmaceuticals Inc.

atorvastatin-10mg-90tab