Application 076402

Type
ANDA
Sponsor
CASI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL5MGNoNo
002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL10MGNoNo
003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL20MGNoNo
004BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL40MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076402-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11
A076402-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11
A076402-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11
A076402-004BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076402-001AB
A076402-002AB
A076402-003AB
A076402-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076402-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076402-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076402-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076402-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076402-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076402-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076402-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076402-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076402-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076402-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076402-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076402-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076402-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076402-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076402-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076402-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076402-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076402-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076402-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076402-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076402-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076402-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076402-004AB1d06236e962d9…

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEANI Pharmaceuticals, Inc.ff732cfa-9ded-4226-b464-19c90a6865ae2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.afd616b9-0c75-48be-862d-5ac18364fd9d2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack58977ec4-36ea-4d81-a8f0-7298425cbc842026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.6dc12ab4-2282-412f-8aa1-46ec5fbbab8f2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDECardinal Health 107, LLCf265e6dd-f47e-4511-9468-282184bcd1b12026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.01a3c9f6-41aa-47a7-8c56-5462c6b544162026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.032ea0f7-3304-4778-b3a6-6125ea7537ab2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited09e383a8-e912-4cf7-8fb3-05545af80dd02026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutions7aac6a2f-85fb-4c7a-b424-9c253186dffe2026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e2026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited67c64de1-5579-46e4-82ee-c9bbee708e022026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf7f9dc46-a947-7ae3-e053-6394a90a11922026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCfc4cd253-13ee-9424-e053-6394a90a35a82026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf32d01db-655b-f3d0-e053-2a95a90a04f62026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf99d3d0d-cee8-b260-e053-6294a90ac3cb2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC3631d1dc-45e1-0588-e054-00144ff88e882026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC708110e5-fa45-44e0-9011-261f4490ea452026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC471cd30a-401a-c8f9-e063-6294a90a47872025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Benazepril Hydrochloride
generic name: BENAZEPRIL HYDROCHLORIDE
LotensinBENAZEPRIL HYDROCHLORIDEValidus Pharmaceuticals LLC2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e2025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BENAZEPRIL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0053Benazepril HydrochlorideBenazepril HydrochlorideEon Labs, Inc.ANDACurrent
0185-0505Benazepril HydrochlorideBenazepril HydrochlorideEon Labs, Inc.ANDACurrent
0185-0820Benazepril HydrochlorideBenazepril HydrochlorideEon Labs, Inc.ANDACurrent
21695-326Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
21695-327Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
21695-612Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
21695-877Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
60429-158Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-158Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-159Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-159Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-160Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-160Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
68788-6361Benazepril HydrochlorideBenazepril HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9946Benazepril HydrochlorideBenazepril HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9947Benazepril HydrochlorideBenazepril HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31118ORIG2004-02-27