ROSUVASTATIN CALCIUM is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Rosuvastatin Calcium.
| Product ID | 76519-1162_5f248416-c8f9-98b2-e053-2991aa0aa855 |
| NDC | 76519-1162 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ROSUVASTATIN CALCIUM |
| Generic Name | Rosuvastatin Calcium |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-01-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA079171 |
| Labeler Name | H. J. Harkins Company Inc. |
| Substance Name | ROSUVASTATIN CALCIUM |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-01-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA079171 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-01-03 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| ROSUVASTATIN CALCIUM | 10 mg/1 |
| SPL SET ID: | 5f248416-c8f8-98b2-e053-2991aa0aa855 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7571 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 0093-7572 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 0093-7573 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 0378-2201 | Rosuvastatin Calcium | rosuvastatin calcium |
| 0378-2203 | Rosuvastatin Calcium | rosuvastatin calcium |
| 0378-2204 | Rosuvastatin Calcium | rosuvastatin calcium |
| 0378-2232 | Rosuvastatin Calcium | rosuvastatin calcium |
| 0781-5400 | Rosuvastatin calcium | Rosuvastatin calcium |
| 67877-440 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 67877-439 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 67877-441 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 67877-442 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68071-3349 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68071-3348 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68071-4765 | Rosuvastatin calcium | Rosuvastatin calcium |
| 68071-4764 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68180-731 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
| 68180-730 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
| 68180-732 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
| 68180-733 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
| 68462-262 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68462-263 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68462-264 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68462-261 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68788-7310 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68788-6823 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 68788-7086 | Rosuvastatin calcium | Rosuvastatin calcium |
| 68788-6955 | Rosuvastatin calcium | Rosuvastatin calcium |
| 69539-007 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 69539-008 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 69539-009 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 69539-010 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 70377-007 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70377-006 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 70377-008 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0002 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 70377-009 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0404 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0484 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0375 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0167 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 70518-1169 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0933 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0963 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-0987 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 70518-1311 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-1444 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 70518-1745 | Rosuvastatin calcium | Rosuvastatin calcium |
| 70518-1819 | Rosuvastatin Calcium | Rosuvastatin Calcium |
| 70518-1726 | Rosuvastatin Calcium | Rosuvastatin Calcium |