Irbesartan
- Product NDC
- 72205-329
- 11-digit product format
- 722050329
- Labeler code
- 72205
- Product ID
- 72205-329_1f98fd95-e564-45b3-947f-45eba77f2af5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA219539
- Marketing category
- ANDA
- Marketing start
- 2025-11-04
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRBESARTAN | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200094, 200095, 200096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-329-05 | Irbesartan | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 72205-329-06 | Irbesartan | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 1 |
| 72205-329-06 | Irbesartan | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 1 |
| 72205-329-30 | Irbesartan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 72205-329-90 | Irbesartan | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 72205-329-99 | Irbesartan | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-329-05 | 72205032905 | 500 TABLET, FILM COATED in 1 BOTTLE (72205-329-05) | | 2025-11-07 | No | No | Current |
| 72205-329-06 | 72205032906 | 10 BLISTER PACK in 1 CARTON (72205-329-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-11-07 | No | No | Current |
| 72205-329-30 | 72205032930 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-329-30) | | 2025-11-07 | No | No | Current |
| 72205-329-90 | 72205032990 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-329-90) | | 2025-11-07 | No | No | Current |
| 72205-329-99 | 72205032999 | 1000 TABLET, FILM COATED in 1 BOTTLE (72205-329-99) | | 2025-11-07 | No | No | Current |