Rosuvastatin
- Product NDC
- 69238-1146
- 11-digit product format
- 692381146
- Labeler code
- 69238
- Product ID
- 69238-1146_da716d5f-ee56-4911-95c9-87d4529067e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA208850
- Marketing category
- ANDA
- Marketing start
- 2018-10-22
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 5 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1146 | ROSUVASTATIN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 12 | Legacy NDC | 20241031_52435b49-6228-4a30-9992-2ea2e77ec7b1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-1146-9 | 69238114609 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1146-9) | 2018-10-22 | 0000-00-00 | No | No | Current |