SIMVASTATIN
- Product NDC
- 68788-8379
- 11-digit product format
- 687888379
- Labeler code
- 68788
- Product ID
- 68788-8379_d2358e56-3e86-4db2-971e-f341d4497eff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- SIMVASTATIN
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| SIMVASTATIN | 40 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 198211 |
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 |
|---|
| 68788-8379-1 | 68788837901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8379-1) | 2022-09-01 | No | No | Historical |
| 68788-8379-3 | 68788837903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8379-3) | 2022-09-01 | No | No | Historical |
| 68788-8379-6 | 68788837906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8379-6) | 2022-09-01 | No | No | Historical |
| 68788-8379-9 | 68788837909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8379-9) | 2022-09-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIMVASTATIN | Preferred Pharmaceuticals Inc. | 2025-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 3 |