Rosuvastatin
- Product NDC
- 68788-8649
- 11-digit product format
- 687888649
- Labeler code
- 68788
- Product ID
- 68788-8649_fea7682a-bb25-4976-8603-e54fbc0f1e50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2024-05-03
- Substance
- ROSUVASTATIN CALCIUM
- 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
- Rosuvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8649-2 | Rosuvastatin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 2 |
| 68788-8649-3 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 68788-8649-6 | Rosuvastatin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 68788-8649-9 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8649 | ROSUVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 4 package rows | 20240531_92a58577-b549-4143-abd0-391a07ed714d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8649-2 | 68788864902 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8649-2) | 2024-05-03 | No | No | Current |
| 68788-8649-3 | 68788864903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8649-3) | 2024-05-03 | No | No | Current |
| 68788-8649-6 | 68788864906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8649-6) | 2024-05-03 | No | No | Current |
| 68788-8649-9 | 68788864909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8649-9) | 2024-05-03 | No | No | Current |