SIMVASTATIN
- Product NDC
- 71610-966
- 11-digit product format
- 716100966
- Labeler code
- 71610
- Product ID
- 71610-966_450e6eb7-f49c-296e-e063-6294a90a05a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2007-06-12
- Substance
- SIMVASTATIN
- Active strength
- 10 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| AGG2FN16EV | SIMVASTATIN | 79902-63-9 | SIMVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-966-30 | 71610096630 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-966-30) | 2025-12-01 | No | No | Historical |
| 71610-966-45 | 71610096645 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-966-45) | 2025-12-01 | No | No | Historical |
| 71610-966-53 | 71610096653 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-966-53) | 2025-12-01 | No | No | Historical |
| 71610-966-60 | 71610096660 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-966-60) | 2025-12-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 2025-12-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |