Label: AMLODIPINE AND ATORVASTATIN tablet, film coated
-
NDC Code(s):
70771-1457-1,
70771-1457-3,
70771-1457-4,
70771-1457-9, view more70771-1458-1, 70771-1458-3, 70771-1458-4, 70771-1458-9, 70771-1459-1, 70771-1459-3, 70771-1459-4, 70771-1459-9, 70771-1460-1, 70771-1460-3, 70771-1460-4, 70771-1460-9, 70771-1461-1, 70771-1461-3, 70771-1461-4, 70771-1461-9, 70771-1462-1, 70771-1462-3, 70771-1462-4, 70771-1462-9, 70771-1463-1, 70771-1463-3, 70771-1463-4, 70771-1463-9, 70771-1464-1, 70771-1464-3, 70771-1464-4, 70771-1464-9, 70771-1465-1, 70771-1465-3, 70771-1465-4, 70771-1465-9, 70771-1466-1, 70771-1466-3, 70771-1466-4, 70771-1466-9, 70771-1467-1, 70771-1467-3, 70771-1467-4, 70771-1467-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Amlodipine and atorvastatin tablets USP, 2.5 mg/ 10 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 2.5 mg/ 20 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 2.5 mg/ 40 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 5 mg/ 10 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 5 mg/ 20 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 5 mg/ 40 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 5 mg/ 80 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 10 mg/ 10 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 10 mg/ 20 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 10 mg/ 40 mg
30 tablets
Rx only
Amlodipine and atorvastatin tablets USP, 10 mg/80 mg
30 tablets
Rx only
-
INGREDIENTS AND APPEARANCE
AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1467 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 10 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 80 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color BLUE (BLUE) Score no score Shape OVAL (BICONVEX) Size 17mm Flavor Imprint Code F14 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1467-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1467-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1467-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1467-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1457 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 2.5 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 424 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1457-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1457-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1457-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1457-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1458 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 2.5 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 425 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1458-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1458-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1458-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1458-4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1459 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 2.5 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 40 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 426 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1459-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1459-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1459-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1459-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1460 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 5 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 9mm Flavor Imprint Code 427 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1460-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1460-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1460-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1460-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1461 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 5 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 11mm Flavor Imprint Code 428 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1461-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1461-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1461-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1461-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1462 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 5 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 40 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 14mm Flavor Imprint Code 429 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1462-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1462-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1462-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1462-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1463 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 5 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 80 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 17mm Flavor Imprint Code 430 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1463-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1463-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1463-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1463-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1464 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 10 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color BLUE (LIGHT BLUE TO BLUE) Score no score Shape OVAL (o) Size 11mm Flavor Imprint Code 431 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1464-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1464-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1464-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1464-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1465 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 10 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color BLUE (LIGHT BLUE TO BLUE) Score no score Shape OVAL (OVAL) Size 11mm Flavor Imprint Code 432 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1465-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1465-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1465-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1465-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 AMLODIPINE AND ATORVASTATINÂ
amlodipine and atorvastatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1466 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 10 mg ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 40 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK)  CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  STARCH, CORN (UNII: O8232NY3SJ)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color BLUE (LIGHT BLUE TO BLUE) Score no score Shape OVAL (OVAL) Size 14mm Flavor Imprint Code 433 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1466-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 2 NDC:70771-1466-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 3 NDC:70771-1466-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 4 NDC:70771-1466-4 10 in 1 CARTON 05/30/2019 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207762 05/30/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1457, 70771-1458, 70771-1459, 70771-1460, 70771-1461, 70771-1462, 70771-1463, 70771-1464, 70771-1465, 70771-1466, 70771-1467) , MANUFACTURE(70771-1457, 70771-1458, 70771-1459, 70771-1460, 70771-1461, 70771-1462, 70771-1463, 70771-1464, 70771-1465, 70771-1466, 70771-1467)