SIMVASTATIN
- Product NDC
- 68071-3426
- 11-digit product format
- 680713426
- Labeler code
- 68071
- Product ID
- 68071-3426_2d58716c-236f-b0e1-e063-6294a90a408e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2016-02-19
- 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 |
|---|
| 68071-3426-3 | 68071342603 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3426-3) | 2023-09-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 2025-02-04 | HUMAN PRESCRIPTION DRUG LABEL | 2 |