Rosuvastatin
- Product NDC
- 61919-786
- 11-digit product format
- 619190786
- Labeler code
- 61919
- Product ID
- 61919-786_eac57eec-996a-fc06-e053-2995a90ac61c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2019-01-14
- 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
- 2023-12-31
- 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 |
|---|
| 61919-786-30 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 61919-786-90 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-786 | ROSUVASTATIN TABLET, FILM COATED [DIRECT_RX] | 3 | Legacy NDC, 2 package rows | 20221012_7f6d9c9d-9065-695b-e053-2a91aa0af650.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 |
|---|
| 61919-786-30 | 61919078630 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-786-30) | 2019-01-14 | 0000-00-00 | No | No | Current |
| 61919-786-90 | 61919078690 | 90 TABLET, FILM COATED in 1 BOTTLE (61919-786-90) | 2019-01-14 | 0000-00-00 | No | No | Current |