Rosuvastatin Calcium
- Product NDC
- 27808-156
- 11-digit product format
- 278080156
- Labeler code
- 27808
- Product ID
- 27808-156_6c4547c4-9429-42e5-998f-e97f6a74f150
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA207408
- Marketing category
- ANDA
- Marketing start
- 2018-01-08
- 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 |
|---|
| 27808-156-01 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
| 27808-156-02 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
| 27808-156-03 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-156 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [CRANBURY PHARMACEUTICALS, LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250330_606d16fb-82e4-420d-9456-09997562b528.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 |
|---|
| 27808-156-01 | 27808015601 | 90 TABLET, FILM COATED in 1 BOTTLE (27808-156-01) | 2018-01-08 | 0000-00-00 | No | No | Current |
| 27808-156-02 | 27808015602 | 1000 TABLET, FILM COATED in 1 BOTTLE (27808-156-02) | 2025-05-01 | | No | No | Historical |
| 27808-156-03 | 27808015603 | 500 TABLET, FILM COATED in 1 BOTTLE (27808-156-03) | 2019-07-26 | 0000-00-00 | No | No | Current |