Benazepril Hydrochloride and Hydrochlorothiazide

Product NDC
0832-0483
11-digit product format
008320483
Labeler code
0832
Product ID
0832-0483_9b4ead99-96a1-4e09-a91b-c7d1cc27b5ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA076631
Marketing category
ANDA
Marketing start
2015-03-16
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
No
Listing certified through
2021-12-31
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 productproduct0832-0483DDiscontinued by firm2026-08-17
excluded packagepackage0832-04830832-0483-11DDiscontinued by firm2026-08-17

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 · 26 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0832-0483-11DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0832-0483-11DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0832-0483-11DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0832-0483-11DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0832-0483-11DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0832-0483-11DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0832-0483-11DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0832-0483-11DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0832-0483-11DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0832-0483-11DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0832-0483-11DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0832-0483-11DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0832-0483-11IInactivated by FDAe2bbac7714bc…27bdfed8d636…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0483-11EA - Each0832-0483c55522fa-9980-4019-8be2-637a95742d7b12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC.]11

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