Home NDC 21695-788 HYZAAR
Product NDC 21695-788
11-digit product format 216950788
Labeler code 21695
Product ID 21695-788_1ac2687d-1a70-4a69-b84c-22840925db09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
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 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 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 21695-788-90 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 21695-788-90 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 21695-788-90 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 21695-788-90 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 21695-788-90 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 21695-788-90 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 21695-788-90 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 21695-788-90 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 21695-788-90 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 21695-788-90 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 21695-788-90 110d247fa046…a55b01930146…
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-788-90 HYZAAR 90 in 1 BOTTLE TABLET, FILM COATED 90 1
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 [REBEL DISTRIBUTORS CORP] 1 losartan potassium ACTIVE INGREDIENT 3ST302B24A HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 hydrochlorothiazide ACTIVE MOIETY 0J48LPH2TH HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 losartan ACTIVE MOIETY JMS50MPO89 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-788 HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 1 package rows 20110113_1ac2687d-1a70-4a69-b84c-22840925db09.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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-788-90 21695078890 90 in 1 BOTTLE Historical