Home NDC 62559-416 Benazepril Hydrochloride and Hydrochlorothiazide
Product NDC 62559-416
11-digit product format 625590416
Labeler code 62559
Product ID 62559-416_052493c7-89a3-452e-8140-04dd95f0d9e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benazepril Hydrochloride and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA076342
Marketing category ANDA
Marketing start 2022-11-07
Substance BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength 20; 12.5 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 2026-12-31
Current FDA listing Yes 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 A076342-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 A076342-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 A076342-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 A076342-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 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 · 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 A076342-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076342-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076342-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076342-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076342-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076342-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076342-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076342-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076342-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076342-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076342-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076342-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076342-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076342-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076342-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076342-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076342-001 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 A076342-002 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 A076342-003 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 A076342-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076342-001 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076342-002 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076342-003 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2004-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076342-004 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 A076342-001 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 A076342-002 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 A076342-003 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 A076342-004 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 A076342-001 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 A076342-002 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 A076342-003 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 A076342-004 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 A076342-001 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 A076342-002 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 A076342-003 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 A076342-004 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 A076342-001 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 A076342-002 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 A076342-003 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 A076342-004 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB 2004-02-11 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 112 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Benazepril Hydrochloride and Hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENAZEPRIL HYDROCHLORIDE 20 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup N1SN99T69T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898362 Internal RxNorm lookup 898367 Internal RxNorm lookup 898372 Internal RxNorm lookup 898378 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62559-416-01 Benazepril Hydrochloride and Hydrochlorothiazide 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-416 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [ANI PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20221107_e6527adf-8c74-4d81-9199-d56a7fca895e.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62559-416-01 62559041601 100 TABLET in 1 BOTTLE (62559-416-01) 100 tablet 2022-11-07 0000-00-00 No No Current