SIMVASTATIN- simvastatin tablet, film coated
Zydus Lifesciences Limited

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SIMVASTATIN TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-065-16 in bottle of 90 tablets

Simvastatin Tablets USP, 5 mg

Rx only

NDC 65841-066-16 in bottle of 90 tablets

Simvastatin Tablets USP, 10 mg

Rx only

NDC 65841-067-16 in bottle of 90 tablets

Simvastatin Tablets USP, 20 mg

Rx only

NDC 65841-068-16 in bottle of 90 tablets

Simvastatin Tablets USP, 40 mg

Rx only

NDC 65841-069-16 in bottle of 90 tablets

Simvastatin Tablets USP, 80 mg

Rx only

SIMVASTATIN
simvastatin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-065
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	5 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	9mm
Flavor		Imprint Code	ZA19
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-065-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
2	NDC:65841-065-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
3	NDC:65841-065-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
4	NDC:65841-065-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
5	NDC:65841-065-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077837	12/20/2006	05/13/2025

SIMVASTATIN
simvastatin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-066
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	10 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK (PINK)	Score	no score
Shape	OVAL (OVAL)	Size	9mm
Flavor		Imprint Code	ZA20
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-066-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
2	NDC:65841-066-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
3	NDC:65841-066-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
4	NDC:65841-066-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
5	NDC:65841-066-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
6	NDC:65841-066-24	10000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077837	12/20/2006	05/13/2025

SIMVASTATIN
simvastatin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-067
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (BROWN)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	ZA21
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-067-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
2	NDC:65841-067-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
3	NDC:65841-067-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
4	NDC:65841-067-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
5	NDC:65841-067-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
6	NDC:65841-067-24	10000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077837	12/20/2006	05/13/2025

SIMVASTATIN
simvastatin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-068
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	40 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK (PINK)	Score	no score
Shape	OVAL (OVAL)	Size	14mm
Flavor		Imprint Code	ZA22
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-068-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
2	NDC:65841-068-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
3	NDC:65841-068-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
4	NDC:65841-068-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
5	NDC:65841-068-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
6	NDC:65841-068-40	5000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077837	12/20/2006	05/13/2025

SIMVASTATIN
simvastatin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-069
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	80 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	ZA23
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-069-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
2	NDC:65841-069-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
3	NDC:65841-069-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
4	NDC:65841-069-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025
5	NDC:65841-069-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077837	12/20/2006	05/13/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-065, 65841-066, 65841-067, 65841-068, 65841-069) , MANUFACTURE(65841-065, 65841-066, 65841-067, 65841-068, 65841-069)

Revised: 12/2024

Document Id: 87333503-61d9-43b1-921b-9edc9e6e14d1

Set id: 881eb80b-712e-4aa2-bd23-290a3e5db6cd

Version: 13

Effective Time: 20241204

Zydus Lifesciences Limited