Rosuvastatin Calcium
- Product NDC
- 65862-294
- 11-digit product format
- 658620294
- Labeler code
- 65862
- Product ID
- 65862-294_d170e87b-de05-4fc4-8e53-9367615e77f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 10 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 | 10 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 |
|---|
| 65862-294-05 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 24 |
| 65862-294-06 | Rosuvastatin Calcium | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 24 |
| 65862-294-06 | Rosuvastatin Calcium | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 24 |
| 65862-294-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 24 |
| 65862-294-90 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 24 |
| 65862-294-99 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-294 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 24 | Current NDC, Legacy NDC, 6 package rows | 20240927_47924917-bbd5-45de-96cb-c7ff9754da97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-294-05 | 65862029405 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-294-05) | | 2016-07-19 | 0000-00-00 | No | No | Current |
| 65862-294-06 | 65862029406 | 10 BLISTER PACK in 1 CARTON (65862-294-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2016-07-19 | 0000-00-00 | No | No | Current |
| 65862-294-30 | 65862029430 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-294-30) | | 2016-07-19 | 0000-00-00 | No | No | Current |
| 65862-294-53 | 65862029453 | 12000 TABLET, FILM COATED in 1 BAG (65862-294-53) | | 19-JUL-16 | | | | Current |
| 65862-294-90 | 65862029490 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-294-90) | | 2016-07-19 | 0000-00-00 | No | No | Current |
| 65862-294-99 | 65862029499 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-294-99) | | 2016-07-19 | 0000-00-00 | No | No | Current |