simvastatin
- Product NDC
- 43063-008
- 11-digit product format
- 430630008
- Labeler code
- 43063
- Product ID
- 43063-008_f162060e-dafd-fe8e-e053-2a95a90a5c4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2008-02-26
- 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
- 2024-12-31
- 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 |
|---|
| 43063-008-30 | 43063000830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-008-30) | 2019-06-07 | 0000-00-00 | No | No | Current |
| 43063-008-90 | 43063000890 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-008-90) | 2017-11-07 | 0000-00-00 | No | No | Current |