Rosuvastatin
- Product NDC
- 31722-882
- 11-digit product format
- 317220882
- Labeler code
- 31722
- Product ID
- 31722-882_49d450b0-95af-a362-e063-6294a90a3e99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2016-10-29
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 5 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-882-01 | Rosuvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 31722-882-05 | Rosuvastatin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 31722-882-31 | Rosuvastatin | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 6 |
| 31722-882-90 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-882 | ROSUVASTATIN (ROSUVASTATIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250213_7778df5a-82c1-4a86-8867-a3325da025ec.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 |
|---|
| 31722-882-01 | 31722088201 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-882-01) | 2024-02-09 | | No | No | Current |
| 31722-882-05 | 31722088205 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-882-05) | 2024-02-09 | | No | No | Current |
| 31722-882-31 | 31722088231 | 100 TABLET, FILM COATED in 1 CARTON (31722-882-31) | 2016-10-29 | 0000-00-00 | No | No | Current |
| 31722-882-90 | 31722088290 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-882-90) | 2016-10-29 | 0000-00-00 | No | No | Current |