Active ingredient
Simvastatin
159 finished FDA listings contain Simvastatin as their only active ingredient; 28 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SIMVASTATIN
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 28
- Strengths listed
- 10 mg/1 · 20 mg/1 · 40 mg/1 · 5 mg/1 · 80 mg/1
- Brand names in FDA listings
- Zocor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 36567
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 019766 | ORGANON | 1991-12-23 | 3 |
| ANDA 077691 | AUROBINDO PHARMA | 2006-12-20 | 31 |
| ANDA 078034 | BIOCON PHARMA | 2006-12-20 | 28 |
| ANDA 078103 | LUPIN | 2007-05-11 | 51 |
| ANDA 078155 | ACCORD HLTHCARE | 2008-02-26 | 27 |
| ANDA 200895 | HETERO LABS LTD III | 2014-11-25 | 15 |
| ANDA 211394 | YILING | 2024-11-27 | 4 |
Official labeling on DailyMed
- SIMVASTATIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 15 · 2026-09-02
- SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] · version 4 · 2026-09-02
- SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] · version 4 · 2026-09-02
- SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] · version 4 · 2026-09-02
- SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-08-31
- SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 8 · 2026-08-20
- SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 1 · 2026-08-17
- SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 11 · 2026-08-07
- SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 8 · 2026-07-09
- SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] · version 1 · 2026-07-08
- SIMVASTATIN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] · version 5 · 2026-07-06
- SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 102 · 2026-06-30
Showing the 12 most recent of 111 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.