Home NDC 0024-5850 Avapro
Product NDC 0024-5850
11-digit product format 000245850
Labeler code 0024
Product ID 0024-5850_cf3ca8df-5a3f-413d-a895-65685cc17313
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
Marketing end 0000-00-00
Substance IRBESARTAN
Active strength 75 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020757-001 AVAPRO IRBESARTAN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 N020757-002 AVAPRO IRBESARTAN 150MG TABLET / ORAL AB RLD 1997-09-30 N020757-003 AVAPRO IRBESARTAN 300MG TABLET / ORAL AB RLD, RS 1997-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0024-5850-30 2024-08-20 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 0024-5850-30 2024-08-20 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 0024-5850-30 2024-08-20 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 0024-5850-90 2024-08-20 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 0024-5850-90 2024-08-20 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 0024-5850-90 2024-08-20 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 0024-5850-30 2024-07-30 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 0024-5850-30 2024-07-30 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 0024-5850-30 2024-07-30 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 0024-5850-90 2024-07-30 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 0024-5850-90 2024-07-30 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 0024-5850-90 2024-07-30 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 0024-5850-30 2024-01-30 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 0024-5850-30 2024-01-30 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 0024-5850-30 2024-01-30 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 0024-5850-90 2024-01-30 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 0024-5850-90 2024-01-30 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 0024-5850-90 2024-01-30 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 Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0024-5850 AVAPRO (IRBESARTAN) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 18 Legacy NDC 20250515_7885b2a8-be4e-48ab-8113-4e6ab791eb98.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Avapro IRBESARTAN Sanofi-Aventis U.S. LLC 7885b2a8-be4e-48ab-8113-4e6ab791eb98 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020757 application number: NDA020757
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 0024-5850-90 00024585090 90 TABLET, FILM COATED in 1 BOTTLE (0024-5850-90) 2013-01-01 0000-00-00 No No Current