Rosuvastatin
- Product NDC
- 68382-627
- 11-digit product format
- 683820627
- Labeler code
- 68382
- Product ID
- 68382-627_1264fa84-af3e-42fe-933c-4c6f62e9b9e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA206513
- Marketing category
- ANDA
- Marketing start
- 2020-01-16
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-627-01 | 68382062701 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-627-01) | | 2020-01-16 | 0000-00-00 | No | No | Current |
| 68382-627-05 | 68382062705 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-627-05) | | 2020-01-16 | 0000-00-00 | No | No | Current |
| 68382-627-06 | 68382062706 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-627-06) | | 2020-01-16 | 0000-00-00 | No | No | Current |
| 68382-627-10 | 68382062710 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-627-10) | | 2020-01-16 | 0000-00-00 | No | No | Current |
| 68382-627-16 | 68382062716 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-627-16) | | 2020-01-16 | 0000-00-00 | No | No | Current |
| 68382-627-77 | 68382062777 | 10 BLISTER PACK in 1 CARTON (68382-627-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-627-30) | 10 blister pack | 2020-01-16 | 0000-00-00 | No | No | Current |