Amlodipine and Atorvastatin

AMLODIPINE AND ATORVASTATIN — amlodipine besylate and atorvastatin calcium trihydrate tablet, film coated
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1457-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1458-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1459-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1460-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1461-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1462-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1463-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 80 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1464-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1465-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1466-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)

NDC 70771-1467-3

Amlodipine and atorvastatin tablets USP, 10 mg/80 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
(click image for full-size original)
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (BLUE) Score no score
Shape OVAL (BICONVEX) Size 17mm
Flavor Imprint Code F14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1467-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1467-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1467-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1467-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1467-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1457
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1457-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1457-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1457-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1457-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1457-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1458
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1458-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1458-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1458-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1458-4 10 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1459
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1459-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1459-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1459-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1459-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1459-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1460
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1460-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1460-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1460-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1460-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1460-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1461
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1461-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1461-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1461-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1461-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1461-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1462
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1462-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1462-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1462-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1462-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1462-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1463
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1463-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1463-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1463-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1463-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1463-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1464
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1464-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1464-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1464-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1464-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1464-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1465
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1465-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1465-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1465-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1465-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1465-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207762 05/30/2019
AMLODIPINE AND ATORVASTATIN
amlodipine and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1466
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:70771-1466-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1466-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1466-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1466-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1466-4)
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 Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1457), ANALYSIS (70771-1458), ANALYSIS (70771-1459), ANALYSIS (70771-1460), ANALYSIS (70771-1461), ANALYSIS (70771-1462), ANALYSIS (70771-1463), ANALYSIS (70771-1464), ANALYSIS (70771-1465), ANALYSIS (70771-1466), ANALYSIS (70771-1467), MANUFACTURE (70771-1457), MANUFACTURE (70771-1458), MANUFACTURE (70771-1459), MANUFACTURE (70771-1460), MANUFACTURE (70771-1461), MANUFACTURE (70771-1462), MANUFACTURE (70771-1463), MANUFACTURE (70771-1464), MANUFACTURE (70771-1465), MANUFACTURE (70771-1466), MANUFACTURE (70771-1467)

Revised: 10/2022 Zydus Lifesciences Limited

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