Irbesartan
- Product NDC
- 71335-1244
- 11-digit product format
- 713351244
- Labeler code
- 71335
- Product ID
- 71335-1244_a542837c-0c20-46b9-8c08-f10acad8fc38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- Substance
- IRBESARTAN
- Active strength
- 150 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| J0E2756Z7N | IRBESARTAN | 138402-11-6 | IRBESARTAN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1244-1 | 71335124401 | 30 TABLET in 1 BOTTLE (71335-1244-1) | 30 tablet | 2019-06-14 | No | No | Historical |
| 71335-1244-2 | 71335124402 | 60 TABLET in 1 BOTTLE (71335-1244-2) | 60 tablet | 2019-06-14 | No | No | Historical |
| 71335-1244-3 | 71335124403 | 90 TABLET in 1 BOTTLE (71335-1244-3) | 90 tablet | 2019-06-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Irbesartan | Bryant Ranch Prepack | 2024-04-03 | HUMAN PRESCRIPTION DRUG LABEL | 3 |