Home NDC 63187-653 Irbesartan and Hydrochlorothiazide
Product NDC 63187-653
11-digit product format 631870653
Labeler code 63187
Product ID 63187-653_2c82bb30-406c-4b3e-9834-ed32ea065bf0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan and Hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA202414
Marketing category ANDA
Marketing start 2012-09-27
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET / ORAL AB 2012-09-27 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET / ORAL AB 2012-09-27
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 3 · 84 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 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202414-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-09-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202414-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-09-27 bb7c543d1eb4…
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 Irbesartan and Hydrochlorothiazide
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 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 63187-653-30 Irbesartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 3 63187-653-60 Irbesartan and Hydrochlorothiazide 60 in 1 BOTTLE TABLET, FILM COATED 60 3 63187-653-90 Irbesartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-653 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 3 package rows 20210113_97b09783-7bba-4f7a-b1b3-86ccf12c7ecc.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 · 3 matching rows.
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 63187-653-30 63187065330 30 TABLET, FILM COATED in 1 BOTTLE (63187-653-30) 2018-12-01 0000-00-00 No No Current 63187-653-60 63187065360 60 TABLET, FILM COATED in 1 BOTTLE (63187-653-60) 2018-12-01 0000-00-00 No No Current 63187-653-90 63187065390 90 TABLET, FILM COATED in 1 BOTTLE (63187-653-90) 2018-12-01 0000-00-00 No No Current