Home NDC 0713-0945 Benicar HCT
Product NDC 0713-0945
11-digit product format 007130945
Labeler code 0713
Product ID 0713-0945_4caff105-c8ff-7873-e063-6294a90a5bfc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil-hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application NDA021532
Marketing category NDA
Marketing start 2026-04-01
Substance HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength 25; 40 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 42 .
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 · 126 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021532-003 BENICAR HCT 12.5MG;40MG TABLET / ORAL AB RLD 2003-06-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021532-005 BENICAR HCT 25MG;40MG TABLET / ORAL AB RLD, RS 2003-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021532-002 BENICAR HCT 12.5MG;20MG TABLET / ORAL AB RLD 2003-06-05 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Benicar HCT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 25 mg/1 HYDROCHLOROTHIAZIDE 40 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 6M97XTV3HD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403853 Internal RxNorm lookup 403854 Internal RxNorm lookup 403855 Internal RxNorm lookup 847042 Internal RxNorm lookup 847055 Internal RxNorm lookup 847060 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 0713-0945-30 Benicar HCT 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1
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 ndc (product): 0713-0945 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 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 0713-0945-30 00713094530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0945-30) 2026-04-01 No No Current