Irbesartan
- Product NDC
- 63187-737
- 11-digit product format
- 631870737
- Labeler code
- 63187
- Product ID
- 63187-737_0adbcb7c-cbd5-49b6-99a4-cdd876ac278a
- 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
- 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 |
|---|
| 63187-737-10 | 63187073710 | 10 BLISTER PACK in 1 CARTON (63187-737-10) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2016-08-01 | No | No | Historical |
| 63187-737-30 | 63187073730 | 30 TABLET in 1 BOTTLE (63187-737-30) | 30 tablet | 2016-08-01 | No | No | Historical |
| 63187-737-60 | 63187073760 | 60 TABLET in 1 BOTTLE (63187-737-60) | 60 tablet | 2016-08-01 | No | No | Historical |
| 63187-737-90 | 63187073790 | 90 TABLET in 1 BOTTLE (63187-737-90) | 90 tablet | 2016-08-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Irbesartan | Proficient Rx LP | 2020-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 4 |