Benazepril Hydrochloride

Product NDC
62559-525
11-digit product format
625590525
Labeler code
62559
Product ID
62559-525_c7a71b00-b447-4a1a-b8dc-6a04467c9268
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA076333
Marketing category
ANDA
Marketing start
2026-07-27
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
10 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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076333-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11
A076333-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11
A076333-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11
A076333-004BENAZEPRIL 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
A076333-001AB
A076333-002AB
A076333-003AB
A076333-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1184e616aacf4f…
2026-08-18 06:07:402026-07A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2004-02-115bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076333-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076333-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076333-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076333-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A076333-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076333-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076333-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076333-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076333-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076333-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076333-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076333-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076333-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076333-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076333-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076333-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076333-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076333-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076333-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076333-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076333-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076333-004AB15bbf6a4d5a75…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE10 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898687Internal RxNorm lookup
898690Internal RxNorm lookup
898719Internal RxNorm lookup
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
ff732cfa-9ded-4226-b464-19c90a6865aeAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEANI Pharmaceuticals, Inc.ff732cfa-9ded-4226-b464-19c90a6865ae2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076333
application number: ANDA076333
ndc (product): 62559-525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-525-0162559052501100 TABLET in 1 BOTTLE (62559-525-01) 100 tablet2026-07-27NoNoCurrent
62559-525-0562559052505500 TABLET in 1 BOTTLE (62559-525-05) 500 tablet2026-07-27NoNoCurrent