Home NDC 71335-1392-2 Irbesartan and Hydrochlorothiazide
Product NDC 71335-1392
Requested package NDC 71335-1392-2
11-digit product format 713351392
Labeler code 71335
Product ID 71335-1392_89701339-861a-4e54-a3d6-cf84046e54f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name irbesartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA020758
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-09-30
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength 13 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 2023-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 N020758-002 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET / ORAL AB RLD, RS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HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-03-15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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1392-1 Irbesartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 3 71335-1392-2 Irbesartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 3 71335-1392-3 Irbesartan and Hydrochlorothiazide 28 in 1 BOTTLE TABLET, FILM COATED 28 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1392 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 3 Legacy NDC, 3 package rows 20240522_89701339-861a-4e54-a3d6-cf84046e54f2.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
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 71335-1392-2 71335139202 90 TABLET, FILM COATED in 1 BOTTLE (71335-1392-2) 2021-12-28 0000-00-00 No No Current