Home NDC 62332-051-91 Irbesartan and Hydrochlorothiazide
Product NDC 62332-051
Requested package NDC 62332-051-91
11-digit product format 623320051
Labeler code 62332
Product ID 62332-051_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 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 2026-08-01 22:54:32 2026-06 A091370-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2012-10-15 a50c72e98297…2026-08-01 22:54:32 2026-06 A091370-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2012-10-15 a50c72e98297…2026-08-01 22:54:32 2026-06 A091370-003 IRBESARTAN AND HYDROCHLOROTHIAZIDE 25MG;300MG TABLET / ORAL AB 2016-10-12 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 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 · 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 62332-051-10 Irbesartan and Hydrochlorothiazide 10 in 1 BLISTER PACK TABLET 10 18 62332-051-30 Irbesartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 18 62332-051-90 Irbesartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET 90 18 62332-051-91 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 62332-051 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
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 62332-051-91 62332005191 1000 TABLET in 1 BOTTLE (62332-051-91) 1000 tablet 2016-05-23 0000-00-00 No No Current