Home NDC 78206-140 HYZAAR
Product NDC 78206-140
11-digit product format 782060140
Labeler code 78206
Product ID 78206-140_10ae5107-90f4-4e30-9320-da164ad71bb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Organon LLC
Application NDA020387
Marketing category NDA
Marketing start 2021-06-01
Substance HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength 12.5; 100 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 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 N020387-001 HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 N020387-002 HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 N020387-003 HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20
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 · 123 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 2026-02-19 14:30 UTC 2026-02 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020387-002 HYZAAR 25MG;100MG TABLET / ORAL AB RLD 1998-11-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020387-003 HYZAAR 12.5MG;100MG TABLET / ORAL AB RLD 2005-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020387-001 HYZAAR 12.5MG;50MG TABLET / ORAL AB RLD 1995-04-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 107 observed states.
Additional Listing Data#
Finished product Yes
Brand name base HYZAAR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOSARTAN POTASSIUM 12.5 mg/1 HYDROCHLOROTHIAZIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3ST302B24A Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979464 Internal RxNorm lookup 979466 Internal RxNorm lookup 979468 Internal RxNorm lookup 979470 Internal RxNorm lookup 979471 Internal RxNorm lookup 979473 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 78206-140-01 HYZAAR 30 in 1 BOTTLE TABLET, FILM COATED 30 10 78206-140-02 HYZAAR 90 in 1 BOTTLE TABLET, FILM COATED 90 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-140 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [ORGANON LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241113_4116ccde-2e23-45f4-b12f-6337df877744.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HYZAAR LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE Organon LLC 4116ccde-2e23-45f4-b12f-6337df877744 2025-11-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020387 application number: NDA020387 ndc (product): 78206-140
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 78206-140-01 78206014001 30 TABLET, FILM COATED in 1 BOTTLE (78206-140-01) 2021-06-01 0000-00-00 No No Current 78206-140-02 78206014002 90 TABLET, FILM COATED in 1 BOTTLE (78206-140-02) 2021-06-01 0000-00-00 No No Current