simvastatin
- Product NDC
- 63187-075
- 11-digit product format
- 631870075
- Labeler code
- 63187
- Product ID
- 63187-075_f5e53eb7-8199-4ca7-9cd0-8dc140c79376
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2008-02-26
- 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 |
|---|
| 63187-075-30 | 63187007530 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-075-30) | 2018-11-01 | No | No | Historical |
| 63187-075-60 | 63187007560 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-075-60) | 2018-11-01 | No | No | Historical |
| 63187-075-90 | 63187007590 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-075-90) | 2018-11-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| simvastatin | Proficient Rx LP | 2022-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 8 |