Simvastatin

Product NDC: 71335-1906
11-digit product format: 713351906
Labeler code: 71335
Product ID: 71335-1906_f12fe783-7679-45af-8e5d-0ea8b31ebaab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078034
Marketing category: ANDA
Marketing start: 2015-12-17
Substance: SIMVASTATIN
Active strength: 40 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

Related Records

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
71335-1906-1	71335190601	30 TABLET, FILM COATED in 1 BOTTLE (71335-1906-1)	2021-07-14	No	No	Historical
71335-1906-2	71335190602	60 TABLET, FILM COATED in 1 BOTTLE (71335-1906-2)	2021-12-29	No	No	Historical
71335-1906-3	71335190603	90 TABLET, FILM COATED in 1 BOTTLE (71335-1906-3)	2021-07-13	No	No	Historical
71335-1906-4	71335190604	180 TABLET, FILM COATED in 1 BOTTLE (71335-1906-4)	2021-12-29	No	No	Historical
71335-1906-5	71335190605	100 TABLET, FILM COATED in 1 BOTTLE (71335-1906-5)	2021-09-29	No	No	Historical
71335-1906-6	71335190606	120 TABLET, FILM COATED in 1 BOTTLE (71335-1906-6)	2021-12-29	No	No	Historical
71335-1906-7	71335190607	28 TABLET, FILM COATED in 1 BOTTLE (71335-1906-7)	2021-12-29	No	No	Historical
71335-1906-8	71335190608	10 TABLET, FILM COATED in 1 BOTTLE (71335-1906-8)	2021-12-29	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Simvastatin	Bryant Ranch Prepack	2024-05-22	HUMAN PRESCRIPTION DRUG LABEL	103