Irbesartan - 0378-2023-05 - (Irbesartan)

Alphabetical Index


Drug Information of Irbesartan

Product NDC: 0378-2023
Proprietary Name: Irbesartan
Non Proprietary Name: Irbesartan
Active Ingredient(s): 150    mg/1 & nbsp;   Irbesartan
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Irbesartan

Product NDC: 0378-2023
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA200461
Marketing Category: ANDA
Start Marketing Date: 20120928

Package Information of Irbesartan

Package NDC: 0378-2023-05
Package Description: 500 TABLET in 1 BOTTLE, PLASTIC (0378-2023-05)

NDC Information of Irbesartan

NDC Code 0378-2023-05
Proprietary Name Irbesartan
Package Description 500 TABLET in 1 BOTTLE, PLASTIC (0378-2023-05)
Product NDC 0378-2023
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Irbesartan
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20120928
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name IRBESARTAN
Strength Number 150
Strength Unit mg/1
Pharmaceutical Classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

Complete Information of Irbesartan


General Information