FDA.reportPublic FDA data

Benazepril Hydrochloride and Hydrochlorothiazide

Product NDC
0378-4745
Requested package NDC
0378-4745-01
11-digit product format
003784745
Labeler code
0378
Product ID
0378-4745_d04e9f2b-42eb-4440-9296-5dea487d3cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benazepril hydrochloride and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076688
Marketing category
ANDA
Marketing start
2004-02-11
Marketing end
0000-00-00
Substance
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength
20 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0378-47450378-4745-01DDiscontinued by firm2026-10-15

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-11
A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-11
A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-11
A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-11

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-11c2088c7a36db…
2026-10-15 13:18:302026-09A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-11c2088c7a36db…
2026-10-15 13:18:302026-09A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-11c2088c7a36db…
2026-10-15 13:18:302026-09A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-11c2088c7a36db…
2026-09-14 22:38:342026-08A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-1184e616aacf4f…
2026-08-18 06:07:402026-07A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076688-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORAL2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076688-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORAL2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076688-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORAL2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076688-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORAL2004-02-112680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076688-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076688-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076688-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076688-004AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076688-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076688-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076688-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076688-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076688-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076688-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076688-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076688-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076688-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076688-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076688-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076688-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076688-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076688-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076688-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076688-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076688-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076688-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076688-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076688-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076688-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076688-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076688-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076688-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076688-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076688-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076688-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076688-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4745-01EA - Each0378-474566c7f9b8-3472-4a3f-9e64-6156dc2e03e712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4745-0100378474501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4745-01) 2004-02-110000-00-00NoNoCurrent