Home
>
National Drug Code (NDC)
>
Irbesartan
Irbesartan - 0054-0252-13 - (Irbesartan)
Drug Information of Irbesartan
| Product NDC: | 0054-0252 |
| Proprietary Name: | Irbesartan |
| Non Proprietary Name: | Irbesartan |
| Active Ingredient(s): | 300 mg/1 & nbsp; Irbesartan |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Irbesartan
| Product NDC: | 0054-0252 |
| Labeler Name: | Roxane Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090201 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121015 |
Package Information of Irbesartan
| Package NDC: | 0054-0252-13 |
| Package Description: | 30 TABLET in 1 BOTTLE (0054-0252-13) |
NDC Information of Irbesartan
| NDC Code | 0054-0252-13 |
| Proprietary Name | Irbesartan |
| Package Description | 30 TABLET in 1 BOTTLE (0054-0252-13) |
| Product NDC | 0054-0252 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Irbesartan |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20121015 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc. |
| Substance Name | IRBESARTAN |
| Strength Number | 300 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] |
