SIMVASTATIN
- Product NDC
- 50090-5788
- 11-digit product format
- 500905788
- Labeler code
- 50090
- Product ID
- 50090-5788_21cfbad6-22fc-424a-87a4-3f4fef24b382
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2016-01-05
- 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
- 2022-12-31
- 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 |
|---|
| 50090-5788-0 | 50090578800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5788-0) | 2021-10-08 | 0000-00-00 | No | No | Current |
| 50090-5788-1 | 50090578801 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5788-1) | 2021-10-08 | 0000-00-00 | No | No | Current |