Simvastatin
- Product NDC
- 50090-7088
- 11-digit product format
- 500907088
- Labeler code
- 50090
- Product ID
- 50090-7088_6c69353b-17c8-4faf-a68f-0326903ba63a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077691
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| AGG2FN16EV | SIMVASTATIN | 79902-63-9 | SIMVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7088-0 | 50090708800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7088-0) | 2024-02-12 | No | No | Historical |
| 50090-7088-1 | 50090708801 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7088-1) | 2024-02-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Simvastatin | A-S Medication Solutions | 2024-02-15 | Human Prescription Drug Label | 1 |