Simvastatin
- Product NDC
- 50090-6389
- 11-digit product format
- 500906389
- Labeler code
- 50090
- Product ID
- 50090-6389_797f8859-cfed-4898-9ff0-d50971e0c7a3
- 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
- 20 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 |
|---|
| 50090-6389-1 | 50090638901 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6389-1) | 2023-03-09 | No | No | Historical |
| 50090-6389-2 | 50090638902 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6389-2) | 2023-03-09 | No | No | Historical |
| 50090-6389-3 | 50090638903 | 200 TABLET, FILM COATED in 1 BOTTLE (50090-6389-3) | 2023-03-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Simvastatin | A-S Medication Solutions | 2023-03-13 | Human Prescription Drug Label | 1 |