Rosuvastatin Calcium
- Product NDC
- 71335-1103
- 11-digit product format
- 713351103
- Labeler code
- 71335
- Product ID
- 71335-1103_b8984684-5f1c-418b-b68d-da6d19987366
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1103-1 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 101 |
| 71335-1103-2 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 101 |
| 71335-1103-3 | Rosuvastatin Calcium | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 101 |
| 71335-1103-4 | Rosuvastatin Calcium | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1103 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 4 package rows | 20231122_8795a783-755d-426b-aa4f-1fc9965ba944.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 |
|---|
| 71335-1103-1 | 71335110301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1103-1) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-1103-2 | 71335110302 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1103-2) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-1103-3 | 71335110303 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1103-3) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-1103-4 | 71335110304 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1103-4) | 2022-02-09 | 0000-00-00 | No | No | Current |