NDC 55289-520
VYTORIN
Ezetimibe And Simvastatin
VYTORIN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Ezetimibe; Simvastatin.
| Product ID | 55289-520_7abb9ad5-a7c2-6395-e053-2a91aa0ad3ab |
| NDC | 55289-520 |
| Product Type | Human Prescription Drug |
| Proprietary Name | VYTORIN |
| Generic Name | Ezetimibe And Simvastatin |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2004-07-23 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021687 |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Substance Name | EZETIMIBE; SIMVASTATIN |
| Active Ingredient Strength | 10 mg/1; mg/1 |
| Pharm Classes | Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 55289-520-30
30 TABLET in 1 BOTTLE, PLASTIC (55289-520-30)
| Marketing Start Date | 2012-01-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 55289-520-30 [55289052030]
VYTORIN TABLET
| Marketing Category | NDA |
| Application Number | NDA021687 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-01-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| EZETIMIBE | 10 mg/1 |
OpenFDA Data
| SPL SET ID: | 3bdbd763-b3e2-4656-8d0a-41a4502647d5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Decreased Cholesterol Absorption [PE]
- Dietary Cholesterol Absorption Inhibitor [EPC]
- HMG-CoA Reductase Inhibitor [EPC]
- Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Crossover Matching brand name "VYTORIN" or generic name "Ezetimibe And Simvastatin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 21695-325 | VYTORIN | ezetimibe and simvastatin |
| 21695-339 | VYTORIN | ezetimibe and simvastatin |
| 21695-827 | VYTORIN | ezetimibe and simvastatin |
| 55289-520 | VYTORIN | VYTORIN |
| 55289-280 | VYTORIN | VYTORIN |
| 66582-311 | VYTORIN | VYTORIN |
| 66582-313 | VYTORIN | VYTORIN |
| 66582-315 | VYTORIN | VYTORIN |
| 66582-312 | VYTORIN | VYTORIN |
| 0115-1385 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN |
| 0115-1386 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN |
| 0115-1387 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN |
| 0115-1388 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN |
| 16714-778 | ezetimibe and simvastatin | ezetimibe and simvastatin |
| 16714-779 | ezetimibe and simvastatin | ezetimibe and simvastatin |
| 16714-780 | ezetimibe and simvastatin | ezetimibe and simvastatin |
| 16714-781 | ezetimibe and simvastatin | ezetimibe and simvastatin |
| 42291-078 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 42291-079 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 42291-080 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 42291-081 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-583 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-584 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-585 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-586 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-742 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-743 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-744 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 43598-745 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
| 45963-565 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin |
Trademark Results [VYTORIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VYTORIN 76492611 2946492 Live/Registered |
MSD INTERNATIONAL GMBH 2003-02-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.