Home NDC 62332-052 Irbesartan and Hydrochlorothiazide
Product NDC 62332-052
11-digit product format 623320052
Labeler code 62332
Product ID 62332-052_08cf62b6-c618-4e6a-877a-4e26ca6e91ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA091370
Marketing category ANDA
Marketing start 2016-05-23
Substance IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength 300; 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 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET / ORAL AB 2012-10-15 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET / ORAL AB 2012-10-15 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET / ORAL AB 2016-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 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 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091370-001 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 A091370-002 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 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091370-001 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 A091370-002 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 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091370-001 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 A091370-002 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 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091370-001 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 A091370-002 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 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091370-001 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 A091370-002 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 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091370-001 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 A091370-002 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 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091370-001 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 A091370-002 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 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091370-001 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 4 · 132 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 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 0J48LPH2TH Internal UNII lookup J0E2756Z7N 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 62332-052-10 Irbesartan and Hydrochlorothiazide 10 in 1 BLISTER PACK TABLET 10 18 62332-052-30 Irbesartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 18 62332-052-90 Irbesartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET 90 18 62332-052-91 Irbesartan and Hydrochlorothiazide 1000 in 1 BOTTLE TABLET 1000 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-052 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] 16 Current NDC, Legacy NDC, 4 package rows 20230906_e842fa14-b18e-4463-9bf1-a1c8700fe33c.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 62332-052-10 62332005210 10 TABLET in 1 BLISTER PACK (62332-052-10) 10 tablet 2016-05-23 0000-00-00 No No Current 62332-052-30 62332005230 30 TABLET in 1 BOTTLE (62332-052-30) 30 tablet 2016-05-23 0000-00-00 No No Current 62332-052-90 62332005290 90 TABLET in 1 BOTTLE (62332-052-90) 90 tablet 2016-05-23 0000-00-00 No No Current 62332-052-91 62332005291 1000 TABLET in 1 BOTTLE (62332-052-91) 1000 tablet 2016-05-23 0000-00-00 No No Current