simvastatin
- Product NDC
- 51655-643
- 11-digit product format
- 516550643
- Labeler code
- 51655
- Product ID
- 51655-643_494f7700-2c27-9b91-e063-6294a90a08ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2020-10-12
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- simvastatin
- Listing expiration
- 2027-12-31
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 |
|---|
| 51655-643-26 | simvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-643 | SIMVASTATIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20241228_f32d512f-86fa-b70f-e053-2a95a90afd01.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-643-26 | 51655064326 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-643-26) | 2020-10-12 | No | No | Current |