NDC Code(s) : 69539-093-30, 69539-093-90, 69539-093-05, 69539-093-99, 69539-094-30, 69539-094-90, 69539-094-05, 69539-094-99, 69539-095-30, 69539-095-90, 69539-095-05, 69539-095-99, 69539-096-30, 69539-096-90, 69539-096-05, 69539-096-99
Packager : MSN LABORATORIES PRIVATE LIMITED

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atorvastatin calcium Atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69539-093
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MAGNESIUM ALUMINOMETASILICATE TYPE I-A(UNII: 7LVU907546)
CALCIUM CARBONATE(UNII: H0G9379FGK)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code MA;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69539-093-3030 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
2NDC:69539-093-9090 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
3NDC:69539-093-05500 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
4NDC:69539-093-991000 in 1 BOTTLE Type 0: Not a Combination Product23/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211933 02/08/2019
Atorvastatin calcium Atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69539-094
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
CALCIUM CARBONATE(UNII: H0G9379FGK)
MAGNESIUM ALUMINOMETASILICATE TYPE I-A(UNII: 7LVU907546)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code MA;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69539-094-3030 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
2NDC:69539-094-9090 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
3NDC:69539-094-05500 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
4NDC:69539-094-991000 in 1 BOTTLE Type 0: Not a Combination Product19/07/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211933 02/08/2019
Atorvastatin calcium Atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69539-095
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
CALCIUM CARBONATE(UNII: H0G9379FGK)
MAGNESIUM ALUMINOMETASILICATE TYPE I-A(UNII: 7LVU907546)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code MA;3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69539-095-3030 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
2NDC:69539-095-9090 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
3NDC:69539-095-05500 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
4NDC:69539-095-991000 in 1 BOTTLE Type 0: Not a Combination Product05/10/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211933 02/08/2019
Atorvastatin calcium Atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:69539-096
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
CALCIUM CARBONATE(UNII: H0G9379FGK)
MAGNESIUM ALUMINOMETASILICATE TYPE I-A(UNII: 7LVU907546)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code MA;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69539-096-3030 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
2NDC:69539-096-9090 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
3NDC:69539-096-05500 in 1 BOTTLE Type 0: Not a Combination Product02/08/2019
4NDC:69539-096-991000 in 1 BOTTLE Type 0: Not a Combination Product05/10/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211933 02/08/2019

LABELER - MSN LABORATORIES PRIVATE LIMITED(650786952)

Establishment
Name Address ID/FEI Business Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS(69539-093, 69539-094, 69539-095, 69539-096), MANUFACTURE(69539-093, 69539-094, 69539-095, 69539-096)

Establishment
Name Address ID/FEI Business Operations
MSN Pharmaceuticals Inc. 079229051 ANALYSIS(69539-093, 69539-094, 69539-095, 69539-096), MANUFACTURE(69539-093, 69539-094, 69539-095, 69539-096)

PRINCIPAL DISPLAY PANEL

10mg-30s-container-label

atorvastatin-10mg-30s-container-label

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40mg-30s-container-label
atorvastatin-10mg-30s-container-label
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atorvastatin-10mg-30s-container-label
40mg-500s-container-label
atorvastatin-10mg-30s-container-label

40mg-1000s-container-label

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atorvastatin-10mg-30s-container-label
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