Home NDC 0054-0255 Irbesartan and Hydrochlorothiazide
Product NDC 0054-0255
11-digit product format 000540255
Labeler code 0054
Product ID 0054-0255_73e2946e-057a-4748-ac8c-13d48bb36599
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA090351
Marketing category ANDA
Marketing start 2012-10-15
Substance HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength 12.5; 300 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 43 .
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 · 129 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090351-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090351-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2017-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090351-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 301d65b070ca…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRBESARTAN 300 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310792 Internal RxNorm lookup 310793 Internal RxNorm lookup 485471 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 0054-0255-13 Irbesartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 21 0054-0255-22 Irbesartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET 90 21 0054-0255-29 Irbesartan and Hydrochlorothiazide 500 in 1 BOTTLE TABLET 500 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 IRBESARTAN ACTIVE INGREDIENT J0E2756Z7N IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 IRBESARTAN ACTIVE MOIETY J0E2756Z7N IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0255 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] 17 Current NDC, Legacy NDC, 3 package rows 20240620_17561aae-f0bc-4ffc-a007-985b17e9baf0.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 0054-0255-13 00054025513 30 TABLET in 1 BOTTLE (0054-0255-13) 30 tablet 2012-10-15 0000-00-00 No No Current 0054-0255-22 00054025522 90 TABLET in 1 BOTTLE (0054-0255-22) 90 tablet 2012-10-15 0000-00-00 No No Current 0054-0255-29 00054025529 500 in 1 BOTTLE Historical