Home NDC 52959-595 Benazepril Hydrochloride and Hydrochlorothiazide
Product NDC 52959-595
11-digit product format 529590595
Labeler code 52959
Product ID 52959-595_db7aec8b-4f85-4358-ba86-b5cbffb6a986
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benazepril Hydrochloride and Hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA076631
Marketing category ANDA
Marketing start 2004-02-11
Marketing end 0000-00-00
Substance BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength 10 mg/1; mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag E
Listing certified through 2018-12-31
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 Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52959-595-60 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52959-595-60 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52959-595-60 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52959-595-60 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52959-595-60 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52959-595-60 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52959-595-60 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52959-595-60 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52959-595-60 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52959-595-60 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52959-595-60 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52959-595-60 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 52959-595-60 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 52959-595-60 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 52959-595-60 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 52959-595-60 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 52959-595-60 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 52959-595-60 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 52959-595-60 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 52959-595-60 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 52959-595-60 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 52959-595-60 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB RS 2004-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 2026-09-14 22:38:34 2026-08 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB RS 2004-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB RS 2004-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB RS 2004-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076631-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076631-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076631-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076631-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 163 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 52959-595-60 Benazepril Hydrochloride and Hydrochlorothiazide 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENAZEPRIL HYDROCHLORIDE ACTIVE INGREDIENT N1SN99T69T BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 BENAZEPRILAT ACTIVE MOIETY JRM708L703 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-595 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 Legacy NDC, 1 package rows 20111221_635634e0-d578-4327-8f8a-4baef830d01d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-595-60 52959059560 60 in 1 BOTTLE Historical