NDC Code(s) : 69844-001-01, 69844-001-02, 69844-001-03, 69844-001-04, 69844-002-01, 69844-002-02, 69844-002-03, 69844-002-04, 69844-003-01, 69844-003-02, 69844-003-03, 69844-003-04, 69844-004-01, 69844-004-02, 69844-004-03, 69844-004-04
Packager : Graviti Pharmaceuticals Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Atorvastatin Calcium atorvastatin calcium, film coated TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-001
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
CALCIUM CARBONATE(UNII: H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code 11
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-001-0130 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
2NDC:69844-001-02100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
3NDC:69844-001-031000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
4NDC:69844-001-0410 in 1 CARTON 18/06/2018
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018
Atorvastatin Calcium atorvastatin calcium, film coated TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-002
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
CALCIUM CARBONATE(UNII: H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code 114
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-002-0130 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
2NDC:69844-002-02100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
3NDC:69844-002-031000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
4NDC:69844-002-0410 in 1 CARTON 18/06/2018
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018
Atorvastatin Calcium atorvastatin calcium, film coated TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-003
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
CALCIUM CARBONATE(UNII: H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code 115
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-003-0130 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
2NDC:69844-003-02100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
3NDC:69844-003-031000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
4NDC:69844-003-0410 in 1 CARTON 18/06/2018
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018
Atorvastatin Calcium atorvastatin calcium, film coated TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-004
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
CALCIUM CARBONATE(UNII: H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off White Oval Shaped Tablet) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code 116
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-004-0130 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
2NDC:69844-004-02100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
3NDC:69844-004-031000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
4NDC:69844-004-0410 in 1 CARTON 18/06/2018
410 in 1 BLISTER PACK Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209912 06/18/2018

LABELER - Graviti Pharmaceuticals Private Limited(650884781)

REGISTRANT - Graviti Pharmaceuticals Private Limited(650884781)

Establishment
Name Address ID/FEI Business Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE(69844-001, 69844-002, 69844-003, 69844-004), ANALYSIS(69844-001, 69844-002, 69844-003, 69844-004)

PRINCIPAL DISPLAY PANEL

NDC 69844-001-01

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

10 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets

NDC 69844-001-04

100 Tablets (10 x 10 Unit-Dose)

Rx only

Atorvastatin Calcium Tablets, USP

10 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 69844-002-01

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

20 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets

NDC 69844-002-04

100 Tablets (10 x 10 Unit-Dose)

Rx only

Atorvastatin Calcium Tablets, USP

20 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 69844-003-01

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

40 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets

NDC 69844-003-04

100 Tablets (10 x 10 Unit-Dose)

Rx only

Atorvastatin Calcium Tablets, USP

40 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 69844-004-01

30 Tablets

Rx only

Atorvastatin Calcium Tablets, USP

80 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets

NDC 69844-004-04

100 Tablets (10 x 10 Unit-Dose)

Rx only

Atorvastatin Calcium Tablets, USP

80 mg*

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

30 Tablets