Rosuvastatin calcium
- Product NDC
- 70377-009
- 11-digit product format
- 703770009
- Labeler code
- 70377
- Product ID
- 70377-009_843cb1f2-e29f-1cea-4a98-e34470827fba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Biocon Pharma Inc
- Application
- ANDA207752
- Marketing category
- ANDA
- Marketing start
- 2016-10-31
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70377-009-11 | 2022-02-10 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
| 70377-009-12 | 2022-02-10 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
| 70377-009-13 | 2022-02-10 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
| 70377-009-15 | 2022-02-10 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
| 70377-009-11 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
| 70377-009-12 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
| 70377-009-13 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
| 70377-009-15 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-0054-a426-e053-dadaa90af4c2 | 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 |
|---|
| 70377-009-11 | Rosuvastatin calcium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 19 |
| 70377-009-12 | Rosuvastatin calcium | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 19 |
| 70377-009-13 | Rosuvastatin calcium | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 19 |
| 70377-009-15 | Rosuvastatin calcium | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-009 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [BIOCON PHARMA INC] | 16 | Current NDC, Legacy NDC, 4 package rows | 20240622_033d8c8f-bbe9-96b5-fd53-cb0ef929857a.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 |
|---|
| 70377-009-11 | 70377000911 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-009-11) | 2016-10-31 | 0000-00-00 | No | No | Current |
| 70377-009-12 | 70377000912 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-009-12) | 2016-10-31 | 0000-00-00 | No | No | Current |
| 70377-009-13 | 70377000913 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-009-13) | 2016-10-31 | 0000-00-00 | No | No | Current |
| 70377-009-15 | 70377000915 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-009-15) | 2019-09-27 | 0000-00-00 | No | No | Current |