Home NDC 42291-925 olmesartan medoxomil-hydrochlorothiazide
Product NDC 42291-925
11-digit product format 422910925
Labeler code 42291
Product ID 42291-925_48bfa982-5678-139d-e063-6294a90adbfa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil-hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application NDA021532
Marketing category NDA
Marketing start 2023-07-27
Substance OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength 40; 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 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 N021532-002 BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 N021532-003 BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 N021532-005 BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05
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 · 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 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 olmesartan medoxomil-hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 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 6M97XTV3HD 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 403853 Internal RxNorm lookup 403854 Internal RxNorm lookup 403855 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-925-90 olmesartan medoxomil-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 42291-925 OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AVKARE] 2 Current NDC, 1 package rows 20230817_017bc6a3-5b3d-2381-e063-6394a90abece.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join olmesartan medoxomil-hydrochlorothiazide OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE AvKARE 569596a2-98f0-116a-e063-6294a90a3fa1 2026-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021532 application number: NDA021532 Benicar HCT OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE Cosette Pharmaceuticals, Inc. a90915ca-f9d3-4fff-8370-d5dc4cdfc521 2026-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021532 application number: NDA021532 olmesartan medoxomil-hydrochlorothiazide OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE AvKARE 017bc6a3-5b3d-2381-e063-6394a90abece 2026-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021532 application number: NDA021532 ndc (product): 42291-925 Benicar HCT OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE Cosette Pharmaceuticals, Inc. 881a1c32-c209-4038-9c5e-c5e46c6e0546 2023-07-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021532 application number: NDA021532
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42291-925-90 42291092590 90 TABLET, FILM COATED in 1 BOTTLE (42291-925-90) 2023-07-27 No No Current