DailyMed - AMLODIPINE AND ATORVASTATIN tablet, film coated

NDC Code(s): 70771-1457-1, 70771-1457-3, 70771-1457-4, 70771-1457-9, view more
70771-1458-1, 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 October 13, 2022

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1457-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 10 mg

30 tablets

Rx only

NDC 70771-1458-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 20 mg

30 tablets

Rx only

NDC 70771-1459-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 40 mg

30 tablets

Rx only

NDC 70771-1460-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 10 mg

30 tablets

Rx only

NDC 70771-1461-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 20 mg

30 tablets

Rx only

NDC 70771-1462-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 40 mg

30 tablets

Rx only

NDC 70771-1463-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 80 mg

30 tablets

Rx only

NDC 70771-1464-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 10 mg

30 tablets

Rx only

NDC 70771-1465-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 20 mg

30 tablets

Rx only

NDC 70771-1466-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 40 mg

30 tablets

Rx only

NDC 70771-1467-3

Amlodipine and atorvastatin tablets USP, 10 mg/80 mg

30 tablets

Rx only

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	80 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	40 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	40 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	80 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	40 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207762	05/30/2019

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
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)

View All Sections

Published Date (What is this?)	Version	Files
Oct 14, 2022	4 (current)	download
Aug 7, 2020	3	download
May 30, 2019	2	download

	RxCUI	RxNorm NAME	RxTTY
1	404011	amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet	PSN
2	404011	amlodipine 5 MG / atorvastatin 80 MG Oral Tablet	SCD
3	404011	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY
4	404013	amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet	PSN
5	404013	amlodipine 10 MG / atorvastatin 80 MG Oral Tablet	SCD
6	404013	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY
7	597967	amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral Tablet	PSN
8	597967	amlodipine 10 MG / atorvastatin 20 MG Oral Tablet	SCD
9	597967	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY
10	597971	amLODIPine besylate 2.5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN
11	597971	amlodipine 2.5 MG / atorvastatin 10 MG Oral Tablet	SCD
12	597971	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY
13	597974	amLODIPine besylate 2.5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN
14	597974	amlodipine 2.5 MG / atorvastatin 20 MG Oral Tablet	SCD
15	597974	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY
16	597977	amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN
17	597977	amlodipine 5 MG / atorvastatin 10 MG Oral Tablet	SCD
18	597977	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY
19	597980	amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN
20	597980	amlodipine 5 MG / atorvastatin 20 MG Oral Tablet	SCD
21	597980	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY
22	597984	amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN
23	597984	amlodipine 5 MG / atorvastatin 40 MG Oral Tablet	SCD
24	597984	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY
25	597987	amLODIPine besylate 10 MG / atorvastatin calcium 10 MG Oral Tablet	PSN
26	597987	amlodipine 10 MG / atorvastatin 10 MG Oral Tablet	SCD
27	597987	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY
28	597990	amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral Tablet	PSN
29	597990	amlodipine 10 MG / atorvastatin 40 MG Oral Tablet	SCD
30	597990	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY
31	597993	amLODIPine besylate 2.5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN
32	597993	amlodipine 2.5 MG / atorvastatin 40 MG Oral Tablet	SCD
33	597993	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY

Label: AMLODIPINE AND ATORVASTATIN tablet, film coated

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	70771-1457-1
2	70771-1457-3
3	70771-1457-4
4	70771-1457-9
5	70771-1458-1
6	70771-1458-3
7	70771-1458-4
8	70771-1458-9
9	70771-1459-1
10	70771-1459-3
11	70771-1459-4
12	70771-1459-9
13	70771-1460-1
14	70771-1460-3
15	70771-1460-4
16	70771-1460-9
17	70771-1461-1
18	70771-1461-3
19	70771-1461-4
20	70771-1461-9
21	70771-1462-1
22	70771-1462-3
23	70771-1462-4
24	70771-1462-9
25	70771-1463-1
26	70771-1463-3
27	70771-1463-4
28	70771-1463-9
29	70771-1464-1
30	70771-1464-3
31	70771-1464-4
32	70771-1464-9
33	70771-1465-1
34	70771-1465-3
35	70771-1465-4
36	70771-1465-9
37	70771-1466-1
38	70771-1466-3
39	70771-1466-4
40	70771-1466-9
41	70771-1467-1
42	70771-1467-3
43	70771-1467-4
44	70771-1467-9

Label: AMLODIPINE AND ATORVASTATIN tablet, film coated

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

AMLODIPINE AND ATORVASTATIN tablet, film coated

Number of versions: 3

AMLODIPINE AND ATORVASTATIN tablet, film coated

AMLODIPINE AND ATORVASTATIN tablet, film coated

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

AMLODIPINE AND ATORVASTATIN tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.