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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
- Listing expiration
- 2026-12-31
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 |
|---|
| 63187-737-10 | Irbesartan | 10 in 1 CARTON | TABLET | 10 | | 4 |
| 63187-737-10 | Irbesartan | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 63187-737-30 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 63187-737-60 | Irbesartan | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 63187-737-90 | Irbesartan | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-737 | IRBESARTAN TABLET [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 5 package rows | 20200116_ada35ec2-8472-411a-8e7c-ff1a0df94ab5.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 |
|---|
| 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 | 0000-00-00 | No | No | Current |
| 63187-737-30 | 63187073730 | 30 TABLET in 1 BOTTLE (63187-737-30) | 30 tablet | 2016-08-01 | 0000-00-00 | No | No | Current |
| 63187-737-60 | 63187073760 | 60 TABLET in 1 BOTTLE (63187-737-60) | 60 tablet | 2016-08-01 | 0000-00-00 | No | No | Current |
| 63187-737-90 | 63187073790 | 90 TABLET in 1 BOTTLE (63187-737-90) | 90 tablet | 2016-08-01 | 0000-00-00 | No | No | Current |