Rosuvastatin
- Product NDC
- 70518-4314
- 11-digit product format
- 705184314
- Labeler code
- 70518
- Product ID
- 70518-4314_3ac089f8-faa3-3cfb-e063-6394a90a9d06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2025-03-19
- 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 |
|---|
| 70518-4314-0 | Rosuvastatin | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 3 |
| 70518-4314-1 | Rosuvastatin | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 3 |
| 70518-4314-2 | 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 |
|---|
| 70518-4314 | ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] | 2 | Current NDC, 3 package rows | 20250423_a370a6c2-b5cd-4aa0-b072-a5a8017a2d5b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4314-0 | 70518431400 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4314-0) | 2025-03-19 | No | No | Historical |
| 70518-4314-1 | 70518431401 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4314-1) | 2025-04-19 | No | No | Historical |
| 70518-4314-2 | 70518431402 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4314-2) | 2025-07-25 | No | No | Historical |