SIMVASTATIN
- Product NDC
- 0615-7992
- 11-digit product format
- 006157992
- Labeler code
- 0615
- Product ID
- 0615-7992_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
- 2007-06-12
- 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
openFDA Listing Details
- Product ID
- 0615-7992_e25097c4-9328-4625-82f4-724d3057ce30
- SPL ID
- e25097c4-9328-4625-82f4-724d3057ce30
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- SIMVASTATIN
- Generic name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2007-06-12
- Marketing category
- ANDA
- Application number
- ANDA078103
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| SIMVASTATIN | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 312961, 314231 |
| Spl Set Id | 1ddc0230-24ab-4e69-9c6c-6776c354c82c |
| Manufacturer Name | NCS HealthCare of KY, LLC dba Vangard Labs |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 0615-7992-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-05) | 2019-04-18 | No |
| 0615-7992-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39) | 2007-06-12 | No |
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 |
|---|
| 0615-7992-05 | 00615799205 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-05) | 2019-04-18 | No | No | Historical |
| 0615-7992-39 | 00615799239 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39) | 2007-06-12 | 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 |