Rosuvastatin Calcium
- Product NDC
- 0904-6778
- 11-digit product format
- 009046778
- Labeler code
- 0904
- Product ID
- 0904-6778_4123d755-6542-42b3-ae0b-9df6c409efdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA201619
- Marketing category
- ANDA
- Marketing start
- 2016-10-31
- 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
- 2022-12-31
- 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 |
|---|
| 0904-6778 | ROSUVASTATIN CALCIUM TABLET, COATED [MAJOR PHARMACEUTICALS] | 11 | Legacy NDC | 20250430_8f2cda59-2bdc-49de-98cd-53ac6b0decdb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6778-61 | 00904677861 | 100 BLISTER PACK in 1 CARTON (0904-6778-61) > 1 TABLET, COATED in 1 BLISTER PACK | 100 blister pack | 2016-10-31 | 0000-00-00 | No | No | Current |