Irbesartan
- Product NDC
- 64980-386
- 11-digit product format
- 649800386
- Labeler code
- 64980
- Product ID
- 64980-386_a4cf687b-71f9-42f3-b18d-523f9cda9986
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA203081
- Marketing category
- ANDA
- Marketing start
- 2017-11-07
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record