Irbesartan
- Product NDC
- 68788-8670
- 11-digit product format
- 687888670
- Labeler code
- 68788
- Product ID
- 68788-8670_c330e536-19dc-475d-8896-871a6c0c80de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2024-05-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRBESARTAN | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200095 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8670-9 | Irbesartan | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8670 | IRBESARTAN TABLET [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20240524_197871da-e0c5-49a9-8dd0-34a8c2685c6b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8670-9 | 68788867009 | 90 TABLET in 1 BOTTLE (68788-8670-9) | 90 tablet | 2024-05-21 | No | No | Historical |