Rosuvastatin Calcium
- Product NDC
- 63629-7158
- 11-digit product format
- 636297158
- Labeler code
- 63629
- Product ID
- 63629-7158_7bb53b84-80ef-49f2-9fdb-678f5301558c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201619
- Marketing category
- ANDA
- Marketing start
- 2016-10-31
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859424 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-7158-1 | 2020-10-16 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
| 63629-7158-2 | 2020-10-16 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
| 63629-7158-3 | 2020-10-16 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
| 63629-7158-4 | 2020-10-16 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
| 63629-7158-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
| 63629-7158-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
| 63629-7158-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
| 63629-7158-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cebd-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-7158-1 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 14 |
| 63629-7158-2 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 14 |
| 63629-7158-3 | Rosuvastatin Calcium | 28 in 1 BOTTLE | TABLET, COATED | 28 | | 14 |
| 63629-7158-4 | Rosuvastatin Calcium | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 14 |
| 63629-7158-5 | Rosuvastatin Calcium | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-7158 | ROSUVASTATIN CALCIUM TABLET, COATED [BRYANT RANCH PREPACK] | 14 | Current NDC, Legacy NDC, 5 package rows | 20241023_1c97c9da-687b-47c1-9b9e-61f9a37bb9c4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-7158-1 | 63629715801 | 30 TABLET, COATED in 1 BOTTLE (63629-7158-1) | 2018-03-16 | 0000-00-00 | No | No | Current |
| 63629-7158-2 | 63629715802 | 90 TABLET, COATED in 1 BOTTLE (63629-7158-2) | 2016-12-09 | 0000-00-00 | No | No | Current |
| 63629-7158-3 | 63629715803 | 28 TABLET, COATED in 1 BOTTLE (63629-7158-3) | 2024-10-08 | 0000-00-00 | No | No | Current |
| 63629-7158-4 | 63629715804 | 60 TABLET, COATED in 1 BOTTLE (63629-7158-4) | 2024-10-08 | 0000-00-00 | No | No | Current |
| 63629-7158-5 | 63629715805 | 100 TABLET, COATED in 1 BOTTLE (63629-7158-5) | 2024-10-08 | 0000-00-00 | No | No | Current |