Rosuvastatin Calcium
- Product NDC
- 53217-295
- 11-digit product format
- 532170295
- Labeler code
- 53217
- Product ID
- 53217-295_6435c10d-3212-426a-95a6-8be7ad65acb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-295-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-295 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20170526_77fd8268-f623-4ba1-b8f3-652f743a4019.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-295-30 | 53217029530 | 30 in 1 BOTTLE | Historical |