simvastatin
- Product NDC
- 68071-4998
- 11-digit product format
- 680714998
- Labeler code
- 68071
- Product ID
- 68071-4998_1b309cb1-49cf-036d-e063-6394a90a0409
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2008-02-26
- 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
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 |
|---|
| 68071-4998-3 | 68071499803 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4998-3) | 2019-07-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| simvastatin | NuCare Pharmaceuticals,Inc. | 2024-06-18 | HUMAN PRESCRIPTION DRUG LABEL | 3 |