Rosuvastatin Calcium
- Product NDC
- 67877-439
- 11-digit product format
- 678770439
- Labeler code
- 67877
- Product ID
- 67877-439_e6a44b24-b851-40c2-92ef-ee7e9fe0d2db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA206465
- Marketing category
- ANDA
- Marketing start
- 2017-03-21
- 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
- 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 | 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 |
|---|
| 67877-439-05 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 27 |
| 67877-439-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 27 |
| 67877-439-38 | Rosuvastatin Calcium | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 27 |
| 67877-439-90 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 27 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-439 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 25 | Current NDC, Legacy NDC, 4 package rows | 20231206_4ccbaa83-d57a-421e-88a8-1cee42d4207b.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 |
|---|
| 67877-439-05 | 67877043905 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-439-05) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 67877-439-30 | 67877043930 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-439-30) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 67877-439-38 | 67877043938 | 10 TABLET, FILM COATED in 1 CARTON (67877-439-38) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 67877-439-90 | 67877043990 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-439-90) | 2017-03-21 | 0000-00-00 | No | No | Current |