Rosuvastatin
- Product NDC
- 71205-044
- 11-digit product format
- 712050044
- Labeler code
- 71205
- Product ID
- 71205-044_99925b18-b0ac-49c2-8cd0-47ec54265506
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2016-10-29
- 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
- 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 |
|---|
| 71205-044-30 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 71205-044-90 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-044 | ROSUVASTATIN TABLET, FILM COATED [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250202_f42139aa-bb38-4791-b41e-cd8f2c922529.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-044-30 | 71205004430 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-044-30) | 2025-01-29 | 0000-00-00 | No | No | Current |
| 71205-044-60 | 71205004460 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-044-60) | 2018-06-01 | 0000-00-00 | No | No | Current |
| 71205-044-90 | 71205004490 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-044-90) | 2018-06-01 | 0000-00-00 | No | No | Current |