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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SIMVASTATIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIMVASTATIN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 312961, 314231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-7992-05 | SIMVASTATIN | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 17 |
| 0615-7992-30 | SIMVASTATIN | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 17 |
| 0615-7992-30 | SIMVASTATIN | 6 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 6 | | 17 |
| 0615-7992-39 | SIMVASTATIN | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-7992 | SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 17 | Current NDC, Legacy NDC, 4 package rows | 20240918_1ddc0230-24ab-4e69-9c6c-6776c354c82c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-7992-05 | 00615799205 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-05) | | 2019-04-18 | 0000-00-00 | No | No | Current |
| 0615-7992-30 | 00615799230 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7992-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 6 blister pack | 2007-06-12 | 0000-00-00 | No | No | Current |
| 0615-7992-39 | 00615799239 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39) | | 2007-06-12 | 0000-00-00 | No | No | Current |