simvastatin
- Product NDC
- 63629-3408
- 11-digit product format
- 636293408
- Labeler code
- 63629
- Product ID
- 63629-3408_8898906b-2d01-44bb-9ebc-b7c7f30e11a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2008-02-26
- 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 |
|---|
| 63629-3408-1 | 63629340801 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-3408-1) | 2024-08-08 | No | No | Historical |
| 63629-3408-2 | 63629340802 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-3408-2) | 2024-08-08 | No | No | Historical |
| 63629-3408-3 | 63629340803 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-3408-3) | 2010-09-27 | No | No | Historical |
| 63629-3408-4 | 63629340804 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-3408-4) | 2009-02-18 | No | No | Historical |
| 63629-3408-5 | 63629340805 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-3408-5) | 2024-08-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| simvastatin | Bryant Ranch Prepack | 2024-08-08 | HUMAN PRESCRIPTION DRUG LABEL | 11 |