Rosuvastatin Calcium
- Product NDC
- 69539-008
- 11-digit product format
- 695390008
- Labeler code
- 69539
- Product ID
- 69539-008_d60d5829-60cf-407c-8b23-45f010949311
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MSN LABORATORIES PRIVATE LIMITED
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- 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
- 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 |
|---|
| 69539-008 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] | 16 | Legacy NDC | 20250201_ec43549b-a0c6-4350-9568-8ebf1766303b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69539-008-05 | 69539000805 | 500 TABLET, FILM COATED in 1 BOTTLE (69539-008-05) | | 2019-02-25 | 0000-00-00 | No | No | Current |
| 69539-008-06 | 69539000806 | 100 BLISTER PACK in 1 CARTON (69539-008-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK (69539-008-11) | 100 blister pack | 2017-11-22 | 0000-00-00 | No | No | Current |
| 69539-008-90 | 69539000890 | 90 TABLET, FILM COATED in 1 BOTTLE (69539-008-90) | | 2017-11-22 | 0000-00-00 | No | No | Current |
| 69539-008-99 | 69539000899 | 1000 TABLET, FILM COATED in 1 BOTTLE (69539-008-99) | | 2017-11-22 | 0000-00-00 | No | No | Current |