Home NDC 0574-0228 benazepril hydrochloride and hydrochlorothiazide
Product NDC 0574-0228
11-digit product format 005740228
Labeler code 0574
Product ID 0574-0228_55072852-c532-448e-935e-102e981cf698
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benazepril hydrochloride and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Padagis US LLC
Application NDA020033
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-04-07
Marketing end 2027-03-31
Substance BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength 20; 25 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
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020033-001 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 N020033-002 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 N020033-003 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET / ORAL AB RLD 1992-05-19 N020033-004 LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 164 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 2026-02-19 14:30 UTC 2026-02 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD 1992-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020033-001 LOTENSIN HCT 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1992-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020033-002 LOTENSIN HCT 10MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020033-003 LOTENSIN HCT 20MG;25MG TABLET / ORAL AB RLD, RS 1992-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020033-004 LOTENSIN HCT 20MG;12.5MG TABLET / ORAL AB RLD 1992-05-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base benazepril hydrochloride and hydrochlorothiazide Active Ingredients# Ingredient, Strength table Ingredient Strength BENAZEPRIL HYDROCHLORIDE 20 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N1SN99T69T Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898362 Internal RxNorm lookup 898367 Internal RxNorm lookup 898372 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 0574-0228-01 benazepril hydrochloride and hydrochlorothiazide 100 in 1 BOTTLE TABLET 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0228 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [PADAGIS US LLC] 6 Current NDC, Legacy NDC, 1 package rows 20230524_3e2d3974-38b0-49d0-8020-f74107584724.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lotensin HCT BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Validus Pharmaceuticals LLC 94c4536f-e28e-48b1-8336-b3939917e99d 2026-02-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020033 application number: NDA020033 benazepril hydrochloride and hydrochlorothiazide BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Advagen Pharma Ltd 3f6e6da8-6da3-47c5-a151-e6fd7206890e 2026-02-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020033 application number: NDA020033 benazepril hydrochloride and hydrochlorothiazide BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack f4120568-dd9b-47a5-bd44-4de6ed343bbe 2024-06-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020033 application number: NDA020033 benazepril hydrochloride and hydrochlorothiazide BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Padagis US LLC 3e2d3974-38b0-49d0-8020-f74107584724 2023-05-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020033 application number: NDA020033 ndc (product): 0574-0228
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 0574-0228-01 00574022801 100 TABLET in 1 BOTTLE (0574-0228-01) 100 tablet 2019-04-07 2027-03-31 No No Current