simvastatin
- Product NDC
- 43353-664
- 11-digit product format
- 433530664
- Labeler code
- 43353
- Product ID
- 43353-664_df1bcbaf-189a-42b4-89ec-121e42efd1a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2008-02-26
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-664-15 | 43353066415 | 15 TABLET, FILM COATED in 1 BOTTLE (43353-664-15) | 2010-10-15 | 0000-00-00 | No | No | Current |
| 43353-664-30 | 43353066430 | 30 TABLET, FILM COATED in 1 BOTTLE (43353-664-30) | 2010-10-15 | 0000-00-00 | No | No | Current |
| 43353-664-45 | 43353066445 | 45 TABLET, FILM COATED in 1 BOTTLE (43353-664-45) | 2010-10-15 | 0000-00-00 | No | No | Current |
| 43353-664-60 | 43353066460 | 90 TABLET, FILM COATED in 1 BOTTLE (43353-664-60) | 2010-10-15 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| simvastatin | Aphena Pharma Solutions - Tennessee, LLC | 2019-12-19 | HUMAN PRESCRIPTION DRUG LABEL | 2 |