Irbesartan and Hydrochlorothiazide
- Product NDC
- 68071-2123
- 11-digit product format
- 680712123
- Labeler code
- 68071
- Product ID
- 68071-2123_46f10483-af5e-46af-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA202414
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN; HYDROCHLOROTHIAZIDE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record