Home NDC 0378-4775 Benazepril Hydrochloride and Hydrochlorothiazide
Product NDC 0378-4775
11-digit product format 003784775
Labeler code 0378
Product ID 0378-4775_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 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 · 24 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 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 0378-4775-01 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076688-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076688-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076688-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL 2004-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076688-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL 2004-02-11 2680178bc6a6…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [MYLAN PHARMACEUTICALS INC.] 6 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 BENAZEPRILAT ACTIVE MOIETY JRM708L703 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-4775-01 00378477501 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4775-01) 2004-02-11 0000-00-00 No No Current