Simvastatin
- Product NDC
- 63629-1198
- 11-digit product format
- 636291198
- Labeler code
- 63629
- Product ID
- 63629-1198_bcf7a690-e4bd-4f49-aa00-e1325909afe4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078034
- Marketing category
- ANDA
- Marketing start
- 2015-12-17
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1198-1 | 63629119801 | 1000 TABLET, FILM COATED in 1 BOTTLE (63629-1198-1) | 2021-01-14 | 0000-00-00 | No | No | Current |