Rosuvastatin calcium
- Product NDC
- 70518-4199
- 11-digit product format
- 705184199
- Labeler code
- 70518
- Product ID
- 70518-4199_3ff4de68-921a-a01d-e063-6294a90a3caf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA079172
- Marketing category
- ANDA
- Marketing start
- 2024-10-01
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 20 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 calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4199-0 | Rosuvastatin calcium | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4199 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20241004_c607da3c-47f5-4773-8391-2a7b0826d30e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4199-0 | 70518419900 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4199-0) | 2024-10-01 | No | No | Current |