IRBESARTAN
- Product NDC
- 62135-978
- 11-digit product format
- 621350978
- Labeler code
- 62135
- Product ID
- 62135-978_352d8ab7-2e21-869d-e063-6294a90ab91f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA077205
- Marketing category
- ANDA
- Marketing start
- 2012-11-14
- 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
- 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 |
|---|
| 62135-978-30 | 62135097830 | 30 TABLET in 1 BOTTLE (62135-978-30) | 30 tablet | 2025-05-06 | No | No | Historical |
| 62135-978-90 | 62135097890 | 90 TABLET in 1 BOTTLE (62135-978-90) | 90 tablet | 2025-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| IRBESARTAN | Chartwell RX, LLC | Chartwell Pharmaceuticals Congers, LLC. | 2025-05-15 | HUMAN PRESCRIPTION DRUG LABEL | 3 |