Home NDC 63629-3183-1 HYZAAR
Product NDC 63629-3183
Requested package NDC 63629-3183-1
11-digit product format 636293183
Labeler code 63629
Product ID 63629-3183_bacd7281-d4fa-4d43-a6cb-d830a664598e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA020387
Marketing category NDA
Marketing start 1995-04-28
Marketing end 0000-00-00
Substance LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength 50 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 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 [BRYANT RANCH PREPACK] 1001 LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 LOSARTAN ACTIVE MOIETY JMS50MPO89 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001
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 63629-3183-1 63629318301 30 TABLET, FILM COATED in 1 BOTTLE (63629-3183-1) 2006-06-13 0000-00-00 No No Current