Rosuvastatin
- Product NDC
- 33342-262
- 11-digit product format
- 333420262
- Labeler code
- 33342
- Product ID
- 33342-262_d7b9f280-bda6-40d4-9778-e45efb87ab23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA207296
- Marketing category
- ANDA
- Marketing start
- 2024-11-06
- 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
- 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 |
|---|
| 33342-262-07 | Rosuvastatin | 30 in 1 CONTAINER | TABLET | 30 | | 1 |
| 33342-262-10 | Rosuvastatin | 90 in 1 CONTAINER | TABLET | 90 | | 1 |
| 33342-262-12 | Rosuvastatin | 10 in 1 CARTON | TABLET | 10 | | 1 |
| 33342-262-12 | Rosuvastatin | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
| 33342-262-44 | Rosuvastatin | 1000 in 1 CONTAINER | TABLET | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-262 | ROSUVASTATIN TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 5 package rows | 20241128_d7b9f280-bda6-40d4-9778-e45efb87ab23.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-262-07 | 33342026207 | 30 TABLET in 1 CONTAINER (33342-262-07) | 30 tablet | 2024-11-06 | No | No | Current |
| 33342-262-10 | 33342026210 | 90 TABLET in 1 CONTAINER (33342-262-10) | 90 tablet | 2024-11-06 | No | No | Current |
| 33342-262-12 | 33342026212 | 10 BLISTER PACK in 1 CARTON (33342-262-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-11-06 | No | No | Current |
| 33342-262-44 | 33342026244 | 1000 TABLET in 1 CONTAINER (33342-262-44) | 1000 tablet | 2024-11-06 | No | No | Current |