ROSUVASTATIN
- Product NDC
- 60505-4502
- 11-digit product format
- 605054502
- Labeler code
- 60505
- Product ID
- 60505-4502_a83a283f-673a-42db-a465-24455cc56457
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROSUVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA079145
- Marketing category
- ANDA
- Marketing start
- 2016-07-20
- Marketing end
- 2021-07-31
- 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
- 0000-00-00
- 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 |
|---|
| 60505-4502-0 | 60505450200 | 10 BLISTER PACK in 1 CARTON (60505-4502-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2016-07-20 | 2021-07-31 | No | No | Current |
| 60505-4502-3 | 60505450203 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4502-3) | | 2016-07-20 | 2021-07-31 | No | No | Current |
| 60505-4502-9 | 60505450209 | 90 TABLET, FILM COATED in 1 BOTTLE (60505-4502-9) | | 2016-07-20 | 2021-07-31 | No | No | Current |