Home NDC 0024-5855 Avalide
Product NDC 0024-5855
11-digit product format 000245855
Labeler code 0024
Product ID 0024-5855_5f9089ce-2d9c-4077-8774-acd86b5eff4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name irbesartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sanofi-Aventis U.S. LLC
Application NDA020758
Marketing category NDA
Marketing start 2013-01-01
Substance HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength 12.5; 150 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020758-001 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 N020758-002 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 N020758-003 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 N020758-004 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15
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 5 · 168 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 2026-08-18 06:07:40 2026-07 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020758-001 AVALIDE 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020758-002 AVALIDE 12.5MG;150MG TABLET / ORAL AB RLD, RS 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020758-003 AVALIDE 12.5MG;300MG TABLET / ORAL AB RLD, RS 1998-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020758-004 AVALIDE 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Avalide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRBESARTAN 12.5 mg/1 HYDROCHLOROTHIAZIDE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup J0E2756Z7N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310792 Internal RxNorm lookup 310793 Internal RxNorm lookup 823934 Internal RxNorm lookup 823938 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0024-5855-30 2024-08-20 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-30 2024-08-20 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-90 2024-08-20 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-90 2024-08-20 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-30 2024-07-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-30 2024-07-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-90 2024-07-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-90 2024-07-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-30 2024-01-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-30 2024-01-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-90 2024-01-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 0024-5855-90 2024-01-30 These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) 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 0024-5855-30 Avalide 30 in 1 BOTTLE TABLET, FILM COATED 30 24 0024-5855-90 Avalide 90 in 1 BOTTLE TABLET, FILM COATED 90 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded hydrochlorothiazide ACTIVE INGREDIENT 0J48LPH2TH AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 irbesartan ACTIVE INGREDIENT J0E2756Z7N AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 hydrochlorothiazide ACTIVE MOIETY 0J48LPH2TH AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 irbesartan ACTIVE MOIETY J0E2756Z7N AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0024-5855 AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] 22 Current NDC, Legacy NDC, 2 package rows 20250519_0d91895e-c869-4b33-9b83-d55c1ad6317e.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 Avalide IRBESARTAN AND HYDROCHLOROTHIAZIDE Sanofi-Aventis U.S. LLC 0d91895e-c869-4b33-9b83-d55c1ad6317e 2025-10-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020758 application number: NDA020758 ndc (product): 0024-5855
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 0024-5855-30 00024585530 30 TABLET, FILM COATED in 1 BOTTLE (0024-5855-30) 2013-01-01 0000-00-00 No No Current 0024-5855-90 00024585590 90 in 1 BOTTLE Historical