Simvastatin
- Product NDC
- 72189-421
- 11-digit product format
- 721890421
- Labeler code
- 72189
- Product ID
- 72189-421_2c4cfec2-fee2-e007-e063-6294a90a3cf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2023-02-07
- 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 |
|---|
| 72189-421-30 | 72189042130 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-421-30) | 2023-02-07 | No | No | Historical |
| 72189-421-90 | 72189042190 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-421-90) | 2023-02-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Simvastatin | Direct_Rx | 2025-01-22 | HUMAN PRESCRIPTION DRUG LABEL | 4 |