Rosuvastatin Calcium
- Product NDC
- 71209-045
- 11-digit product format
- 712090045
- Labeler code
- 71209
- Product ID
- 71209-045_e931da38-899a-4efb-9d6c-42e3a6a1b56f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cadila Pharmaceuticals Limited
- Application
- ANDA207453
- Marketing category
- ANDA
- Marketing start
- 2017-03-24
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin Calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71209-045-04 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71209-045 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240929_6802a946-a29c-4d41-997b-3c078ed8e74d.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 |
|---|
| 71209-045-04 | 71209004504 | 90 TABLET, FILM COATED in 1 BOTTLE (71209-045-04) | 2018-11-21 | 0000-00-00 | No | No | Current |