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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-595IInactivated by FDA2026-08-17
excluded packagepackage52959-59552959-595-60IInactivated by FDA2026-08-17

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-595-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-595-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-595-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-595-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-595-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-595-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-595-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-595-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-595-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-595-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-595-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-595-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-595-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-595-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-595-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52959-595-60IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52959-595-60IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52959-595-60IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52959-595-60IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52959-595-60IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52959-595-60IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52959-595-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11
A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11
A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11
A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALABRS2004-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076631-001AB
A076631-002AB
A076631-003AB
A076631-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALABRS2004-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALABRS2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-11d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 159 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076631-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076631-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076631-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076631-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076631-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076631-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-004AB1d8e5a09893c0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-595-602020-01-31C16284748780-19d75b9d0-87be-f424-e053-dadaa90a57ceBenazepril Hydrochloride and Hydrochlorothiazide Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-595-60Benazepril Hydrochloride and Hydrochlorothiazide60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-595BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 1 package rows20111221_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDESandoz Incc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f2025-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076631
application number: ANDA076631
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA51b0aed8-a229-4d2c-8fdf-aa957fddc41b2023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076631
application number: ANDA076631

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898362benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN635634e0-d578-4327-8f8a-4baef830d01d3
898362benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD635634e0-d578-4327-8f8a-4baef830d01d3
898362benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY635634e0-d578-4327-8f8a-4baef830d01d3
898362BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY635634e0-d578-4327-8f8a-4baef830d01d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-595-605295905956060 in 1 BOTTLEHistorical