SIMVASTATIN
- Product NDC
- 68788-8342
- 11-digit product format
- 687888342
- Labeler code
- 68788
- Product ID
- 68788-8342_e1169d33-e736-4322-acdd-cf52f7eb042c
- 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
- 2023-02-03
- 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 |
|---|
| 68788-8342-1 | 68788834201 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8342-1) | 2023-02-03 | No | No | Historical |
| 68788-8342-3 | 68788834203 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8342-3) | 2023-02-03 | No | No | Historical |
| 68788-8342-6 | 68788834206 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8342-6) | 2023-02-03 | No | No | Historical |
| 68788-8342-9 | 68788834209 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8342-9) | 2023-02-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIMVASTATIN | Preferred Pharmaceuticals, Inc. | 2025-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 3 |