Simvastatin
- Product NDC
- 55154-4782
- 11-digit product format
- 551544782
- Labeler code
- 55154
- Product ID
- 55154-4782_403c6eb1-a14f-48d9-a329-b1a7a78029b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2011-05-02
- Substance
- SIMVASTATIN
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 312961 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-4782-0 | Simvastatin | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 14 |
| 55154-4782-0 | Simvastatin | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-4782 | SIMVASTATIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240927_b2d6c7ac-304b-4cba-974c-d9a23a069925.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 |
|---|
| 55154-4782-0 | 55154478200 | 10 BLISTER PACK in 1 BAG (55154-4782-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-05-02 | 0000-00-00 | No | No | Current |