Simvastatin
- Product NDC
- 71610-609
- 11-digit product format
- 716100609
- Labeler code
- 71610
- Product ID
- 71610-609_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
- 20 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 |
|---|
| 71610-609-45 | 71610060945 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-609-45) | 2021-10-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Simvastatin | Aphena Pharma Solutions - Tennessee, LLC | 2023-03-20 | HUMAN PRESCRIPTION DRUG LABEL | 2 |