Rosuvastatin Calcium
- Product NDC
- 68788-7612
- 11-digit product format
- 687887612
- Labeler code
- 68788
- Product ID
- 68788-7612_ca11474d-6cdb-4777-9c5a-7229dd83452e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2020-06-01
- 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
- 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7612-2 | Rosuvastatin Calcium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
| 68788-7612-3 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 68788-7612-6 | Rosuvastatin Calcium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 68788-7612-9 | Rosuvastatin Calcium | 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 |
|---|
| 68788-7612 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240808_6ef51f7c-2899-4b09-bf8b-09e5b4ac3424.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 |
|---|
| 68788-7612-2 | 68788761202 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-7612-2) | 2020-06-01 | 0000-00-00 | No | No | Current |
| 68788-7612-3 | 68788761203 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7612-3) | 2020-06-01 | 0000-00-00 | No | No | Current |
| 68788-7612-6 | 68788761206 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7612-6) | 2020-06-01 | 0000-00-00 | No | No | Current |
| 68788-7612-9 | 68788761209 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7612-9) | 2020-06-01 | 0000-00-00 | No | No | Current |