Benazepril Hydrochloride

Product NDC
43063-677
11-digit product format
430630677
Labeler code
43063
Product ID
43063-677_2fb04f78-5c4d-59d2-e063-6294a90a4b8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
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 42.

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
A076118-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11
A076118-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11
A076118-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11
A076118-004BENAZEPRIL 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
A076118-001AB
A076118-002AB
A076118-003AB
A076118-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076118-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076118-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076118-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076118-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076118-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076118-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076118-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076118-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076118-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076118-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076118-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076118-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076118-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N1SN99T69TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898690Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a7b373a-9b74-4b9d-93fb-081614222e30Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-677-30Benazepril Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, COATED3018
43063-677-90Benazepril Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-677-30EA - Each43063-67791e52fdc-a8c8-4710-9e4d-eda5de181bed12020-05-08
43063-677-90EA - Each43063-677334cc3f6-768f-48f6-8179-7e4e1335d58f12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-677BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 2 package rows20250309_1a7b373a-9b74-4b9d-93fb-081614222e30.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.afd616b9-0c75-48be-862d-5ac18364fd9d2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.01a3c9f6-41aa-47a7-8c56-5462c6b544162026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.032ea0f7-3304-4778-b3a6-6125ea7537ab2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutions7aac6a2f-85fb-4c7a-b424-9c253186dffe2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC3631d1dc-45e1-0588-e054-00144ff88e882026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC708110e5-fa45-44e0-9011-261f4490ea452026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC471cd30a-401a-c8f9-e063-6294a90a47872025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutions6c24bb4c-42d2-483a-b33f-95182b32b93d2025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutions8f46e2c9-9b3b-48d0-a307-9069e38799592025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEGolden State Medical Supply, Inc.cb93e793-fe4f-452c-e053-2995a90a73332025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a7b373a-9b74-4b9d-93fb-081614222e302025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
ndc (product): 43063-677
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.355811f0-2885-0d49-e054-00144ff8d46c2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.55c99902-3d4d-05e9-e054-00144ff8d46c2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.4d5a8b50-dd2f-4329-9e28-93608e8fe8da2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDEDIRECT RXa7e4e43a-7abc-e2a5-e053-2995a90ab5f42025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack08bc0034-3b33-47d8-aec2-b36535ac85a22024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack0653322d-70c6-45f7-a9d1-41efee1d73872024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.7274fdaf-1247-2b2f-e053-2991aa0ad3f62024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.700c828c-86c6-1857-e053-2a91aa0ae3142024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.9535ec77-2d50-4817-e053-2995a90a007e2024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076118
application number: ANDA076118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN1a7b373a-9b74-4b9d-93fb-081614222e3018
898690benazepril hydrochloride 20 MG Oral TabletSCD1a7b373a-9b74-4b9d-93fb-081614222e3018
898690BZP hydrochloride 20 MG Oral TabletSY1a7b373a-9b74-4b9d-93fb-081614222e3018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-677-304306306773030 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-677-30) 2016-06-090000-00-00NoNoCurrent
43063-677-904306306779090 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-677-90) 2024-06-07NoNoCurrent