ROSUVASTATIN CALCIUM
- Product NDC
- 48792-7883
- 11-digit product format
- 487927883
- Labeler code
- 48792
- Product ID
- 48792-7883_a33aa36a-c9ec-7f02-e053-2995a90a58db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sunshine Lake Pharma Co., Ltd.
- Application
- ANDA210667
- Marketing category
- ANDA
- Marketing start
- 2020-04-14
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 48792-7883-1 | 48792788301 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7883-1) | 2020-04-14 | 0000-00-00 | No | No | Current |