ROSUVASTATIN CALCIUM
- Product NDC
- 70518-0375
- 11-digit product format
- 705180375
- Labeler code
- 70518
- Product ID
- 70518-0375_eb522f65-f140-5c70-e053-2995a90abe90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROSUVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206434
- Marketing category
- ANDA
- Marketing start
- 2017-06-05
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0375-0 | 70518037500 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0375-0) | 2017-06-05 | 0000-00-00 | No | No | Current |
| 70518-0375-1 | 70518037501 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0375-1) | 2018-11-07 | 0000-00-00 | No | No | Current |
| 70518-0375-2 | 70518037502 | 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0375-2) | 2019-01-24 | 0000-00-00 | No | No | Current |
| 70518-0375-3 | 70518037503 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0375-3) | 2022-10-17 | 0000-00-00 | No | No | Current |