Home NDC 71335-1787 Irbesartan and Hydrochlorothiazide
Product NDC 71335-1787
11-digit product format 713351787
Labeler code 71335
Product ID 71335-1787_1c842673-6489-419f-a5f3-7a3454a43efb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090351
Marketing category ANDA
Marketing start 2012-10-15
Substance IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength 150; 12.5 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET / ORAL 2012-10-15 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET / ORAL 2012-10-15 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET / ORAL 2017-06-08
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 · 132 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 2026-10-15 13:18:30 2026-09 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2012-10-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2012-10-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL 2017-06-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2012-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2012-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL 2017-06-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2012-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2012-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL 2017-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Irbesartan and Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRBESARTAN 150 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J0E2756Z7N Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310792 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1787-1 Irbesartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 104 71335-1787-2 Irbesartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET 90 104 71335-1787-3 Irbesartan and Hydrochlorothiazide 28 in 1 BOTTLE TABLET 28 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1787 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 3 package rows 20240524_e6c35575-9c3f-42f8-b8b8-577a29f9d381.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 · 2 matching rows.
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 71335-1787-1 71335178701 30 TABLET in 1 BOTTLE (71335-1787-1) 30 tablet 2021-08-12 0000-00-00 No No Current 71335-1787-2 71335178702 90 TABLET in 1 BOTTLE (71335-1787-2) 90 tablet 2021-12-20 0000-00-00 No No Current 71335-1787-3 71335178703 28 TABLET in 1 BOTTLE (71335-1787-3) 28 tablet 2021-12-20 0000-00-00 No No Current