Rosuvastatin Calcium
- Product NDC
- 68788-7566
- 11-digit product format
- 687887566
- Labeler code
- 68788
- Product ID
- 68788-7566_92373744-faac-40e9-9798-8c89815d4a46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-7566-2 | 2022-02-14 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
| 68788-7566-3 | 2022-02-14 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
| 68788-7566-6 | 2022-02-14 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
| 68788-7566-9 | 2022-02-14 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
| 68788-7566-2 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
| 68788-7566-3 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
| 68788-7566-6 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
| 68788-7566-9 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e28e-a426-e053-dadaa90af4c2 | 9a2c6345-b4a3-45e8-8816-55a75fb9eb68 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7566-2 | EA - Each | 68788-7566 | e5677084-6d63-4f90-8a6e-8077d607936a | 1 | 2020-08-06 |
| 68788-7566-3 | EA - Each | 68788-7566 | 174e3434-bb32-446d-b31f-84feb22204be | 1 | 2020-08-06 |
| 68788-7566-6 | EA - Each | 68788-7566 | 444bcf43-9e57-4c2b-ba8d-857ff33f6d17 | 1 | 2020-08-06 |
| 68788-7566-9 | EA - Each | 68788-7566 | 85a19417-83c8-4de9-b8d9-2c12955db614 | 1 | 2020-08-06 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7566-2 | 68788756602 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-7566-2) | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7566-3 | 68788756603 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7566-3) | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7566-6 | 68788756606 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7566-6) | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7566-9 | 68788756609 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7566-9) | 2019-12-27 | 0000-00-00 | No | No | Current |