ROSUVASTATIN CALCIUM
- Product NDC
- 43353-339
- 11-digit product format
- 433530339
- Labeler code
- 43353
- Product ID
- 43353-339_6398df0f-8c43-4428-b882-3f5efb53ae00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROSUVASTATIN CALCIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2017-02-02
- 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
- 2020-12-31
- 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 |
|---|
| 43353-339 | ROSUVASTATIN CALCIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20170714_15e4e32c-e9d4-4bff-9529-448a4f066fd1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-339-19 | 43353033919 | 3060 TABLET in 1 BOTTLE (43353-339-19) | 3060 tablet | 2017-05-26 | 0000-00-00 | No | No | Current |