Simvastatin

Product NDC: 71610-611
11-digit product format: 716100611
Labeler code: 71610
Product ID: 71610-611_ed131a35-eda8-4cdb-a6f0-eae48ea1c59e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078034
Marketing category: ANDA
Marketing start: 2015-12-17
Substance: SIMVASTATIN
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71610-611_ed131a35-eda8-4cdb-a6f0-eae48ea1c59e
SPL ID: ed131a35-eda8-4cdb-a6f0-eae48ea1c59e
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Simvastatin
Generic name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2015-12-17
Marketing category: ANDA
Application number: ANDA078034
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
SIMVASTATIN	80 mg/1

Field	Values
Unii	AGG2FN16EV
Rxcui	198211, 200345, 312961
Spl Set Id	c0a303c5-6277-47ce-bb8a-bd5400fd8261
Manufacturer Name	Aphena Pharma Solutions - Tennessee, LLC

Package NDC	Description	Marketing start	Sample
71610-611-45	45 TABLET, FILM COATED in 1 BOTTLE (71610-611-45)	2021-10-25	No

UNII	Preferred term	Registry number	Matched term
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-611-45	71610061145	45 TABLET, FILM COATED in 1 BOTTLE (71610-611-45)	2021-10-25	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	2023-03-20	HUMAN PRESCRIPTION DRUG LABEL	2