IRBESARTAN
- Product NDC
- 72189-201
- 11-digit product format
- 721890201
- Labeler code
- 72189
- Product ID
- 72189-201_2c290c08-d35e-21b4-e063-6394a90a73b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- direct rx
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2021-04-13
- 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
openFDA Listing Details
- Product ID
- 72189-201_2c290c08-d35e-21b4-e063-6394a90a73b9
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- IRBESARTAN
- Generic name
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2021-04-13
- Marketing category
- ANDA
- Application number
- ANDA202910
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| IRBESARTAN | 75 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200094, 200095, 200096 |
| Spl Set Id | bfdf76ae-fedf-630c-e053-2995a90a9868 |
| Manufacturer Name | direct rx |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 72189-201-90 | 72189020190 | 90 TABLET in 1 BOTTLE (72189-201-90) | 90 tablet | 2021-04-13 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| IRBESARTAN | direct rx | 2025-01-20 | HUMAN PRESCRIPTION DRUG LABEL | 5 |