Rosuvastatin
- Product NDC
- 70518-4303
- 11-digit product format
- 705184303
- Labeler code
- 70518
- Product ID
- 70518-4303_39e35072-2886-20fc-e063-6394a90aa36e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2025-03-04
- Substance
- ROSUVASTATIN
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 413KH5ZJ73 |
| Rxcui | 859747 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4303-0 | Rosuvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 5 |
| 70518-4303-1 | Rosuvastatin | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 5 |
| 70518-4303-2 | Rosuvastatin | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 5 |
| 70518-4303-3 | Rosuvastatin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4303 | ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] | 4 | Current NDC, 4 package rows | 20250429_b8b29392-85fa-417b-bd10-10ab0d07381f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4303-0 | 70518430300 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4303-0) | 2025-03-04 | No | No | Current |
| 70518-4303-1 | 70518430301 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4303-1) | 2025-03-28 | No | No | Current |
| 70518-4303-2 | 70518430302 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4303-2) | 2025-04-25 | No | No | Current |
| 70518-4303-3 | 70518430303 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4303-3) | 2025-07-13 | No | No | Current |