Simvastatin
- Product NDC
- 50268-716
- 11-digit product format
- 502680716
- Labeler code
- 50268
- Product ID
- 50268-716_d5dfc011-59be-26d0-e053-2a95a90a9212
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA077691
- Marketing category
- ANDA
- Marketing start
- 2014-12-02
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-716-15 | 50268071615 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-716-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-716-11) | 50 blister pack | 2014-12-02 | 0000-00-00 | No | No | Current |