Rosuvastatin
- Product NDC
- 71335-9669
- 11-digit product format
- 713359669
- Labeler code
- 71335
- Product ID
- 71335-9669_5c1a3549-fe1f-4fcd-ad0b-248bf18ffd47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2016-10-29
- 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
- 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 | 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-9669-1 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 102 |
| 71335-9669-2 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 102 |
| 71335-9669-3 | Rosuvastatin | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 102 |
| 71335-9669-4 | Rosuvastatin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 102 |
| 71335-9669-5 | Rosuvastatin | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 102 |
| 71335-9669-6 | Rosuvastatin | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-9669 | ROSUVASTATIN (ROSUVASTATIN) TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, 6 package rows | 20250303_e6b86b67-62c7-43cc-8174-b2b8e0a60711.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9669-1 | 71335966901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9669-1) | 2026-04-13 | No | No | Historical |
| 71335-9669-2 | 71335966902 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9669-2) | 2023-04-04 | No | No | Historical |
| 71335-9669-3 | 71335966903 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9669-3) | 2026-04-13 | No | No | Historical |
| 71335-9669-4 | 71335966904 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9669-4) | 2026-04-13 | No | No | Historical |
| 71335-9669-5 | 71335966905 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9669-5) | 2026-04-13 | No | No | Historical |
| 71335-9669-6 | 71335966906 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9669-6) | 2026-04-13 | No | No | Historical |