CRESTOR
- Product NDC
- 63629-3381
- 11-digit product format
- 636293381
- Labeler code
- 63629
- Product ID
- 63629-3381_1a69848d-95d7-41e8-a3a0-aa5367d4f03b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA021366
- Marketing category
- NDA
- Marketing start
- 2003-08-18
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-3381-1 | 2020-07-21 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
| 63629-3381-2 | 2020-07-21 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
| 63629-3381-3 | 2020-07-21 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
| 63629-3381-4 | 2020-07-21 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
| 63629-3381-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
| 63629-3381-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
| 63629-3381-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
| 63629-3381-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e32c-f424-e053-dadaa90a57ce | 1a69848d-95d7-41e8-a3a0-aa5367d4f03b |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-3381-1 | EA - Each | 63629-3381 | 045c3691-be85-43eb-9ae8-33373b48d154 | 1 | 2015-10-02 |
| 63629-3381-2 | EA - Each | 63629-3381 | 32dddadd-6392-4e75-af5e-0316ea17654b | 1 | 2015-10-02 |
| 63629-3381-3 | EA - Each | 63629-3381 | f0c14d66-07f9-4b20-aada-5ff73956c283 | 1 | 2015-10-02 |
| 63629-3381-4 | EA - Each | 63629-3381 | 19303ff2-8b51-4219-b72b-7d52005d54a3 | 1 | 2015-10-02 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-3381-1 | 63629338101 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-3381-1) | 2010-08-27 | 0000-00-00 | No | No | Current |
| 63629-3381-2 | 63629338102 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-3381-2) | 2010-08-27 | 0000-00-00 | No | No | Current |
| 63629-3381-3 | 63629338103 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-3381-3) | 2010-08-27 | 0000-00-00 | No | No | Current |
| 63629-3381-4 | 63629338104 | 180 TABLET, FILM COATED in 1 BOTTLE (63629-3381-4) | 2010-08-27 | 0000-00-00 | No | No | Current |