Benazepril Hydrochloride

Product NDC
68071-3324
11-digit product format
680713324
Labeler code
68071
Product ID
68071-3324_1cd70bab-30c9-fbdd-e063-6294a90a7df3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
5 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

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 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-3324-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-3324-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-3324-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-3324-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-3324-68af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-3324-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-3324-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-3324-6834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-3324-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-3324-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-3324-61332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-3324-11332a3947898…d4bfe170f9cd…

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 HYDROCHLORIDE5 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
898723Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53fea330-cc4a-3b7e-e054-00144ff88e88Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-3324-12024-07-09These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-32024-07-09These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-62024-07-09These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-12023-01-30These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-32023-01-30These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-62023-01-30These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-12021-02-12These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-32021-02-12These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-62021-02-12These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-12021-01-29These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-32021-01-29These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
68071-3324-62021-01-29These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3324-1Benazepril Hydrochloride120 in 1 BOTTLETABLET, COATED1204
68071-3324-3Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED304
68071-3324-6Benazepril Hydrochloride60 in 1 BOTTLETABLET, COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3324BENAZEPRIL HYDROCHLORIDE TABLET, COATED [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240711_53fea330-cc4a-3b7e-e054-00144ff88e88.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
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
898723benazepril HCl 5 MG Oral TabletPSN53fea330-cc4a-3b7e-e054-00144ff88e884
898723benazepril hydrochloride 5 MG Oral TabletSCD53fea330-cc4a-3b7e-e054-00144ff88e884
898723benazepril HCl 5 MG Oral TabletSY53fea330-cc4a-3b7e-e054-00144ff88e884
898723BZP hydrochloride 5 MG Oral TabletSY53fea330-cc4a-3b7e-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3324-168071332401120 TABLET, COATED in 1 BOTTLE (68071-3324-1) 2017-07-100000-00-00NoNoCurrent
68071-3324-36807133240330 TABLET, COATED in 1 BOTTLE (68071-3324-3) 2017-07-100000-00-00NoNoCurrent
68071-3324-66807133240660 TABLET, COATED in 1 BOTTLE (68071-3324-6) 2017-07-100000-00-00NoNoCurrent