DailyMed - SIMVASTATIN tablet, film coated

NDC Code(s): 65841-065-05, 65841-065-06, 65841-065-10, 65841-065-14, view more
65841-065-16, 65841-066-05, 65841-066-06, 65841-066-10, 65841-066-14, 65841-066-16, 65841-066-24, 65841-067-05, 65841-067-06, 65841-067-10, 65841-067-14, 65841-067-16, 65841-067-24, 65841-068-05, 65841-068-06, 65841-068-10, 65841-068-14, 65841-068-16, 65841-068-40, 65841-069-05, 65841-069-06, 65841-069-10, 65841-069-14, 65841-069-16
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 17, 2022

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SPL UNCLASSIFIED SECTION
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

INGREDIENTS AND APPEARANCE

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
Packaging
1	NDC:65841-065-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
2	NDC:65841-065-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
3	NDC:65841-065-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
4	NDC:65841-065-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
5	NDC:65841-065-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006

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

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
Packaging
1	NDC:65841-066-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
2	NDC:65841-066-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
3	NDC:65841-066-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
4	NDC:65841-066-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
5	NDC:65841-066-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
6	NDC:65841-066-24	10000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006

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

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
Packaging
1	NDC:65841-067-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
2	NDC:65841-067-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
3	NDC:65841-067-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
4	NDC:65841-067-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
5	NDC:65841-067-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
6	NDC:65841-067-24	10000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006

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

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
Packaging
1	NDC:65841-068-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
2	NDC:65841-068-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
3	NDC:65841-068-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
4	NDC:65841-068-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
5	NDC:65841-068-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
6	NDC:65841-068-40	5000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006

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

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
Packaging
1	NDC:65841-069-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
2	NDC:65841-069-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
3	NDC:65841-069-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
4	NDC:65841-069-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006
5	NDC:65841-069-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2006

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

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)

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Published Date (What is this?)	Version	Files
Oct 19, 2022	12 (current)	download
Sep 21, 2020	11	download
Sep 3, 2019	9	download
Apr 22, 2019	8	download
Dec 17, 2018	7	download
Mar 27, 2018	6	download
Nov 30, 2017	5	download
Apr 8, 2013	4	download
Dec 7, 2011	3	download
Aug 12, 2011	2	download
Apr 1, 2011	1	download

	RxCUI	RxNorm NAME	RxTTY
1	198211	simvastatin 40 MG Oral Tablet	PSN
2	198211	simvastatin 40 MG Oral Tablet	SCD
3	200345	simvastatin 80 MG Oral Tablet	PSN
4	200345	simvastatin 80 MG Oral Tablet	SCD
5	312961	simvastatin 20 MG Oral Tablet	PSN
6	312961	simvastatin 20 MG Oral Tablet	SCD
7	312962	simvastatin 5 MG Oral Tablet	PSN
8	312962	simvastatin 5 MG Oral Tablet	SCD
9	314231	simvastatin 10 MG Oral Tablet	PSN
10	314231	simvastatin 10 MG Oral Tablet	SCD

Label: SIMVASTATIN tablet, film coated

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	NDC
1	65841-065-05
2	65841-065-06
3	65841-065-10
4	65841-065-14
5	65841-065-16
6	65841-066-05
7	65841-066-06
8	65841-066-10
9	65841-066-14
10	65841-066-16
11	65841-066-24
12	65841-067-05
13	65841-067-06
14	65841-067-10
15	65841-067-14
16	65841-067-16
17	65841-067-24
18	65841-068-05
19	65841-068-06
20	65841-068-10
21	65841-068-14
22	65841-068-16
23	65841-068-40
24	65841-069-05
25	65841-069-06
26	65841-069-10
27	65841-069-14
28	65841-069-16

Label: SIMVASTATIN tablet, film coated

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More Info For This Drug

Drug Label Information

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More Info on this Drug

SIMVASTATIN tablet, film coated

Number of versions: 11

SIMVASTATIN tablet, film coated

SIMVASTATIN tablet, film coated

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SIMVASTATIN tablet, film coated

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