Rosuvastatin
- Product NDC
- 70518-4098
- 11-digit product format
- 705184098
- Labeler code
- 70518
- Product ID
- 70518-4098_3fa44de4-fc4f-4980-e063-6294a90a8d35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2024-06-07
- 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 | 859424 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4098-0 | Rosuvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
| 70518-4098-1 | Rosuvastatin | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 3 |
| 70518-4098-2 | Rosuvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4098 | ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] | 2 | Current NDC, 3 package rows | 20240927_6ebaefa9-2c71-4777-8730-83cf5ae737cc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4098-0 | 70518409800 | 90 in 1 BOTTLE, PLASTIC | | | | Historical |
| 70518-4098-1 | 70518409801 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4098-1) | 2024-08-08 | No | No | Current |
| 70518-4098-2 | 70518409802 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4098-2) | 2024-09-24 | No | No | Current |