Rosuvastatin Calcium
- Product NDC
- 70518-3651
- 11-digit product format
- 705183651
- Labeler code
- 70518
- Product ID
- 70518-3651_4f6f28e5-216c-7d9c-e063-6394a90a27d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207408
- Marketing category
- ANDA
- Marketing start
- 2023-02-19
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin Calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3651-0 | Rosuvastatin Calcium | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 8 |
| 70518-3651-1 | Rosuvastatin Calcium | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 8 |
| 70518-3651-2 | Rosuvastatin Calcium | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 8 |
| 70518-3651-3 | Rosuvastatin Calcium | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3651 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] | 5 | Current NDC, 4 package rows | 20250423_d9b83920-26ae-462a-ac10-33fd1ed7738f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3651-0 | 70518365100 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-0) | 2023-02-19 | No | No | Historical |
| 70518-3651-1 | 70518365101 | 45 in 1 BOTTLE, PLASTIC | | | | Historical |
| 70518-3651-2 | 70518365102 | 30 in 1 BLISTER PACK | | | | Historical |
| 70518-3651-3 | 70518365103 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-3) | 2025-04-21 | No | No | Historical |