SIMVASTATIN
- Product NDC
- 71205-798
- 11-digit product format
- 712050798
- Labeler code
- 71205
- Product ID
- 71205-798_dad0dd7d-3049-4be4-aaeb-8a1895d55208
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2007-06-12
- Substance
- SIMVASTATIN
- Active strength
- 10 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 |
|---|
| 71205-798-30 | 71205079830 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-798-30) | 2023-05-05 | No | No | Historical |
| 71205-798-60 | 71205079860 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-798-60) | 2023-05-05 | No | No | Historical |
| 71205-798-90 | 71205079890 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-798-90) | 2023-05-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIMVASTATIN | Proficient Rx LP | 2023-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |