Irbesartan
- Product NDC
- 71335-2168
- 11-digit product format
- 713352168
- Labeler code
- 71335
- Product ID
- 71335-2168_f8e0d3a4-3293-4db6-861a-238dd17c9d45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203071
- Marketing category
- ANDA
- Marketing start
- 2016-06-13
- 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 |
|---|
| 71335-2168-1 | 71335216801 | 30 TABLET in 1 BOTTLE (71335-2168-1) | 30 tablet | 2022-09-06 | No | No | Historical |
| 71335-2168-2 | 71335216802 | 60 TABLET in 1 BOTTLE (71335-2168-2) | 60 tablet | 2022-09-06 | No | No | Historical |
| 71335-2168-3 | 71335216803 | 90 TABLET in 1 BOTTLE (71335-2168-3) | 90 tablet | 2022-09-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Irbesartan | Bryant Ranch Prepack | 2023-11-27 | HUMAN PRESCRIPTION DRUG LABEL | 101 |