Simvastatin
- Product NDC
- 68382-065
- 11-digit product format
- 683820065
- Labeler code
- 68382
- Product ID
- 68382-065_e092e3e3-d4b5-4714-b8f9-27c70ba79f2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA077837
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 5 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 |
|---|
| 68382-065-05 | 68382006505 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-065-05) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 68382-065-06 | 68382006506 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-065-06) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 68382-065-10 | 68382006510 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-065-10) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 68382-065-14 | 68382006514 | 60 TABLET, FILM COATED in 1 BOTTLE (68382-065-14) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 68382-065-16 | 68382006516 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-065-16) | 2006-12-20 | 0000-00-00 | No | No | Current |