Home NDC 55289-522 HYZAAR
Product NDC 55289-522
11-digit product format 552890522
Labeler code 55289
Product ID 55289-522_d290f942-4fd5-2af9-e053-2995a90a548d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020387
Marketing category NDA
Marketing start 1995-04-28
Marketing end 0000-00-00
Substance LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength 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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-522-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-522-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-522-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-522-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-522-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-522-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-522-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-522-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-522-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-522-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-522-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-522-30 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded hydrochlorothiazide ACTIVE INGREDIENT 0J48LPH2TH HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 losartan potassium ACTIVE INGREDIENT 3ST302B24A HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 hydrochlorothiazide ACTIVE MOIETY 0J48LPH2TH HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 losartan ACTIVE MOIETY JMS50MPO89 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 magnesium stearate INACTIVE INGREDIENT 70097M6I30 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-522-30 55289052230 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-522-30) 2011-11-21 0000-00-00 No No Current