Rosuvastatin Calcium
- Product NDC
- 71205-390
- 11-digit product format
- 712050390
- Labeler code
- 71205
- Product ID
- 71205-390_b2f702dc-1c6e-4217-b88a-1cc8a54fbb1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA207408
- Marketing category
- ANDA
- Marketing start
- 2018-01-08
- 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 | 859419, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-390-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 71205-390-60 | Rosuvastatin Calcium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 71205-390-90 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-390 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20220602_dcc22d05-cff6-42f9-b9fa-930f2084753f.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 |
|---|
| 71205-390-30 | 71205039030 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-390-30) | 2020-01-28 | 0000-00-00 | No | No | Current |
| 71205-390-60 | 71205039060 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-390-60) | 2020-01-28 | 0000-00-00 | No | No | Current |
| 71205-390-90 | 71205039090 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-390-90) | 2020-01-28 | 0000-00-00 | No | No | Current |