Avapro
- Product NDC
- 0024-5852
- 11-digit product format
- 000245852
- Labeler code
- 0024
- Product ID
- 0024-5852_b36c9035-33ad-4c8f-b47f-030436e0ef4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- irbesartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sanofi-Aventis U.S. LLC
- Application
- NDA020757
- Marketing category
- NDA
- Marketing start
- 2013-01-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Avapro
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRBESARTAN | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 153666, 153667, 200095, 200096 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0024-5852-30 | 2024-08-20 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-08-20 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-08-20 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-08-20 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-08-20 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-08-20 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-07-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-07-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-07-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-07-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-07-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-07-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
| 0024-5852-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-684f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0024-5852-30 | Avapro | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 21 |
| 0024-5852-90 | Avapro | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0024-5852 | AVAPRO (IRBESARTAN) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] | 18 | Current NDC, Legacy NDC, 2 package rows | 20250515_7885b2a8-be4e-48ab-8113-4e6ab791eb98.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0024-5852-30 | 00024585230 | 30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30) | 2013-01-01 | 0000-00-00 | No | No | Current |
| 0024-5852-90 | 00024585290 | 90 in 1 BOTTLE | | | | | Historical |