Irbesartan
- Product NDC
- 50090-2017
- 11-digit product format
- 500902017
- Labeler code
- 50090
- Product ID
- 50090-2017_6fdd10d2-4cb2-4631-bc45-744660ae5bb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- 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 | 200095, 200096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-2017-0 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 23 |
| 50090-2017-1 | Irbesartan | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-2017 | IRBESARTAN TABLET IRBESARTAN TABLET [A-S MEDICATION SOLUTIONS] | 23 | Current NDC, Legacy NDC, 2 package rows | 20231222_868bd0a7-38ff-4722-8063-a697af3be527.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-2017-0 | 50090201700 | 30 TABLET in 1 BOTTLE (50090-2017-0) | 30 tablet | 2015-09-21 | 0000-00-00 | No | No | Current |
| 50090-2017-1 | 50090201701 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-2017-1) | 90 tablet | 2014-11-28 | 0000-00-00 | No | No | Current |