Irbesartan
- Product NDC
- 0054-0252
- 11-digit product format
- 000540252
- Labeler code
- 0054
- Product ID
- 0054-0252_7d783004-ef17-4dcb-a3d9-4a965116ad4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA090201
- Marketing category
- ANDA
- Marketing start
- 2012-10-15
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record