SIMVASTATIN
- Product NDC
- 0615-7993
- 11-digit product format
- 006157993
- Labeler code
- 0615
- Product ID
- 0615-7993_e25097c4-9328-4625-82f4-724d3057ce30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2007-06-14
- 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 |
|---|
| 0615-7993-05 | 00615799305 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7993-05) | 2018-09-21 | No | No | Historical |
| 0615-7993-39 | 00615799339 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7993-39) | 2007-06-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIMVASTATIN | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-09-13 | HUMAN PRESCRIPTION DRUG LABEL | 17 |