Irbesartan
- Product NDC
- 71205-379
- 11-digit product format
- 712050379
- Labeler code
- 71205
- Product ID
- 71205-379_003c2047-0d19-4a1c-b162-31ef2c319faf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202254
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- Substance
- IRBESARTAN
- Active strength
- 75 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 |
|---|
| 71205-379-30 | 71205037930 | 30 TABLET in 1 BOTTLE (71205-379-30) | 30 tablet | 2020-01-06 | No | No | Historical |
| 71205-379-60 | 71205037960 | 60 TABLET in 1 BOTTLE (71205-379-60) | 60 tablet | 2020-01-06 | No | No | Historical |
| 71205-379-90 | 71205037990 | 90 TABLET in 1 BOTTLE (71205-379-90) | 90 tablet | 2020-01-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Irbesartan | Proficient Rx LP | 2022-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |