Simvastatin
- Product NDC
- 65841-069
- 11-digit product format
- 658410069
- Labeler code
- 65841
- Product ID
- 65841-069_f6a1f948-fffb-40ff-a5fc-e6767c93957d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA077837
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 80 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 |
|---|
| 65841-069-05 | 65841006905 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-069-05) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65841-069-06 | 65841006906 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-069-06) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65841-069-10 | 65841006910 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-069-10) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65841-069-14 | 65841006914 | 60 TABLET, FILM COATED in 1 BOTTLE (65841-069-14) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65841-069-16 | 65841006916 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-069-16) | 2006-12-20 | 0000-00-00 | No | No | Current |