Simvastatin
- Product NDC
- 10544-487
- 11-digit product format
- 105440487
- Labeler code
- 10544
- Product ID
- 10544-487_46615c70-6322-4bcb-a8bb-c76e79f8bcff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA077837
- Marketing category
- ANDA
- Marketing start
- 2015-02-27
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-487-30 | Simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 10544-487-90 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-487 | SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20151230_4fd79a00-7215-4fb5-8284-688687d99bef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-487-30 | 10544048730 | 30 in 1 BOTTLE | Historical |
| 10544-487-90 | 10544048790 | 90 in 1 BOTTLE | Historical |