SIMVASTATIN
- Product NDC
- 0615-8056
- 11-digit product format
- 006158056
- Labeler code
- 0615
- Product ID
- 0615-8056_d4f96add-3a0f-4a00-9fa5-d73852230543
- 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
- 2015-12-02
- Substance
- SIMVASTATIN
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 198211 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8056-05 | SIMVASTATIN | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 7 |
| 0615-8056-39 | SIMVASTATIN | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8056 | SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 7 | Current NDC, Legacy NDC, 2 package rows | 20220927_8850724a-a431-46e5-b88e-1d77b0b62d6e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8056-05 | 00615805605 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-05) | 2019-04-01 | 0000-00-00 | No | No | Current |
| 0615-8056-39 | 00615805639 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-39) | 2015-12-02 | 0000-00-00 | No | No | Current |