Simvastatin
- Product NDC
- 82009-015
- 11-digit product format
- 820090015
- Labeler code
- 82009
- Product ID
- 82009-015_1de47781-9000-0fc1-e063-6294a90a8139
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA200895
- Marketing category
- ANDA
- Marketing start
- 2022-05-26
- 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, 200345, 312961, 312962, 314231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-015-10 | Simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-015 | SIMVASTATIN (SIMVASTATIN) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240724_2b4255a7-f9f5-4235-8dbb-b0f03acbd624.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 |
|---|
| 82009-015-10 | 82009001510 | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-015-10) | 2022-05-26 | 0000-00-00 | No | No | Current |