Irbesartan
- Product NDC
- 50090-1284
- 11-digit product format
- 500901284
- Labeler code
- 50090
- Product ID
- 50090-1284_6fdd10d2-4cb2-4631-bc45-744660ae5bb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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 |
|---|
| 50090-1284-0 | 50090128400 | 30 TABLET in 1 BOTTLE (50090-1284-0) | 30 tablet | 2014-11-28 | No | No | Historical |
| 50090-1284-1 | 50090128401 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-1284-1) | 90 tablet | 2014-11-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Irbesartan | A-S Medication Solutions | 2023-12-21 | HUMAN PRESCRIPTION DRUG LABEL | 23 |