Rosuvastatin
- Product NDC
- 51407-848
- 11-digit product format
- 514070848
- Labeler code
- 51407
- Product ID
- 51407-848_32d8af6b-ed18-ad03-e063-6394a90a078d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- Substance
- ROSUVASTATIN
- Active strength
- 5 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
- Rosuvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 413KH5ZJ73 |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51407-848-10 | Rosuvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 51407-848-90 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-848 | ROSUVASTATIN TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 3 | Current NDC, 2 package rows | 20250424_0f02c184-49f3-8fa6-e063-6394a90a5092.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51407-848-10 | 51407084810 | 1000 TABLET, FILM COATED in 1 BOTTLE (51407-848-10) | 2023-12-18 | No | No | Current |
| 51407-848-90 | 51407084890 | 90 TABLET, FILM COATED in 1 BOTTLE (51407-848-90) | 2023-12-18 | No | No | Current |