Rosuvastatin
- Product NDC
- 71335-2498
- 11-digit product format
- 713352498
- Labeler code
- 71335
- Product ID
- 71335-2498_029a4920-fc8c-466d-a283-2ec641d445ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- Substance
- ROSUVASTATIN
- 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 413KH5ZJ73 |
| Rxcui | 859419 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2498-1 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 71335-2498-2 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 71335-2498-3 | Rosuvastatin | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 2 |
| 71335-2498-4 | Rosuvastatin | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 2 |
| 71335-2498-5 | Rosuvastatin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2498 | ROSUVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] | 2 | Current NDC, 5 package rows | 20241122_e4f6f29b-9d44-4389-9aa8-01000f94775e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2498-1 | 71335249801 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2498-1) | 2024-10-14 | No | No | Current |
| 71335-2498-2 | 71335249802 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2498-2) | 2024-10-14 | No | No | Current |
| 71335-2498-3 | 71335249803 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2498-3) | 2024-11-01 | No | No | Current |
| 71335-2498-4 | 71335249804 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2498-4) | 2024-11-01 | No | No | Current |
| 71335-2498-5 | 71335249805 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2498-5) | 2024-11-01 | No | No | Current |