Benazepril Hydrochloride

Product NDC
65862-118
11-digit product format
658620118
Labeler code
65862
Product ID
65862-118_0e5c3b12-afaa-4816-9af8-ebf2363dcef2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078212
Marketing category
ANDA
Marketing start
2008-05-22
Marketing end
2026-11-30
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-118UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage65862-11865862-118-61UNFINISHEDActive or certified unfinished drug listing2026-08-17
excluded packagepackage65862-11865862-118-90DDiscontinued by firm2026-08-17

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-118-61a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-118-611d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-118-61390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-118-61e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-118-61bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-118-61f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-118-61f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-118-6168b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-118-6105c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-118-6148b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-118-6127f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-118-618d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-118-61d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-118-6150b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-118-61906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-118-616db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-118-618fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-118-614184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-118-614bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-118-61263afe128892…91768de4ddbe…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078212-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22
A078212-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22
A078212-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078212-001AB
A078212-002AB
A078212-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-221e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078212-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078212-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078212-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078212-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078212-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE40 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898687Internal RxNorm lookup
898690Internal RxNorm lookup
898719Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09e383a8-e912-4cf7-8fb3-05545af80dd0Available 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
65862-118-01Benazepril Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10026
65862-118-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-118-01EA - Each65862-11862f39a4e-f783-4061-ab7f-b5fa2acec69212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-118BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]25Current NDC, Legacy NDC, 2 package rows20240509_09e383a8-e912-4cf7-8fb3-05545af80dd0.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack58977ec4-36ea-4d81-a8f0-7298425cbc842026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited09e383a8-e912-4cf7-8fb3-05545af80dd02026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
ndc (product): 65862-118
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited67c64de1-5579-46e4-82ee-c9bbee708e022026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf7f9dc46-a947-7ae3-e053-6394a90a11922026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCfc4cd253-13ee-9424-e053-6394a90a35a82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf32d01db-655b-f3d0-e053-2a95a90a04f62026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsfade97e1-8400-4214-b750-e7656cae7a0f2025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.91a3d0f7-d2df-4230-ad9e-b32f7312d3372025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.9016634a-1bdd-700d-e053-2995a90a8f272024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.800f2a14-98b9-3499-e053-2991aa0a197d2024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutionse0d5362b-f5da-4838-ae91-22f40fcca2452023-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsc5090372-41bf-4677-b198-97fd55a0cb872023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEProficient Rx LP92a26516-3d84-4d7a-a770-5239265078872019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSN5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c30
898719benazepril hydrochloride 40 MG Oral TabletSCD5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c30
898719BZP hydrochloride 40 MG Oral TabletSY5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c30
898687benazepril HCl 10 MG Oral TabletPSN09e383a8-e912-4cf7-8fb3-05545af80dd026
898690benazepril HCl 20 MG Oral TabletPSN09e383a8-e912-4cf7-8fb3-05545af80dd026
898719benazepril HCl 40 MG Oral TabletPSN09e383a8-e912-4cf7-8fb3-05545af80dd026
898687benazepril hydrochloride 10 MG Oral TabletSCD09e383a8-e912-4cf7-8fb3-05545af80dd026
898690benazepril hydrochloride 20 MG Oral TabletSCD09e383a8-e912-4cf7-8fb3-05545af80dd026
898719benazepril hydrochloride 40 MG Oral TabletSCD09e383a8-e912-4cf7-8fb3-05545af80dd026
898687BZP hydrochloride 10 MG Oral TabletSY09e383a8-e912-4cf7-8fb3-05545af80dd026
898690BZP hydrochloride 20 MG Oral TabletSY09e383a8-e912-4cf7-8fb3-05545af80dd026
898719BZP hydrochloride 40 MG Oral TabletSY09e383a8-e912-4cf7-8fb3-05545af80dd026
898719benazepril HCl 40 MG Oral TabletPSN800f2a14-98b9-3499-e053-2991aa0a197d5
898719benazepril HCl 40 MG Oral TabletPSNc5090372-41bf-4677-b198-97fd55a0cb875
898719benazepril HCl 40 MG Oral TabletPSN58977ec4-36ea-4d81-a8f0-7298425cbc845
898719benazepril hydrochloride 40 MG Oral TabletSCD58977ec4-36ea-4d81-a8f0-7298425cbc845
898719benazepril hydrochloride 40 MG Oral TabletSCD800f2a14-98b9-3499-e053-2991aa0a197d5
898719benazepril hydrochloride 40 MG Oral TabletSCDc5090372-41bf-4677-b198-97fd55a0cb875
898719BZP hydrochloride 40 MG Oral TabletSY800f2a14-98b9-3499-e053-2991aa0a197d5
898719BZP hydrochloride 40 MG Oral TabletSYc5090372-41bf-4677-b198-97fd55a0cb875
898719BZP hydrochloride 40 MG Oral TabletSY58977ec4-36ea-4d81-a8f0-7298425cbc845
898719benazepril HCl 40 MG Oral TabletPSN9016634a-1bdd-700d-e053-2995a90a8f273
898719benazepril HCl 40 MG Oral TabletPSNf32d01db-655b-f3d0-e053-2a95a90a04f63
898719benazepril hydrochloride 40 MG Oral TabletSCD9016634a-1bdd-700d-e053-2995a90a8f273
898719benazepril hydrochloride 40 MG Oral TabletSCDf32d01db-655b-f3d0-e053-2a95a90a04f63
898719BZP hydrochloride 40 MG Oral TabletSY9016634a-1bdd-700d-e053-2995a90a8f273
898719BZP hydrochloride 40 MG Oral TabletSYf32d01db-655b-f3d0-e053-2a95a90a04f63
898719benazepril HCl 40 MG Oral TabletPSN92a26516-3d84-4d7a-a770-5239265078872
898719benazepril hydrochloride 40 MG Oral TabletSCD92a26516-3d84-4d7a-a770-5239265078872
898719BZP hydrochloride 40 MG Oral TabletSY92a26516-3d84-4d7a-a770-5239265078872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-118-0165862011801100 TABLET, FILM COATED in 1 BOTTLE (65862-118-01) 2008-05-222026-11-30NoNoCurrent
65862-118-61658620118616000 TABLET, FILM COATED in 1 BAG (65862-118-61)22-MAY-0830-NOV-26Historical
65862-118-906586201189090 TABLET, FILM COATED in 1 BOTTLE (65862-118-90) 2008-05-220000-00-00NoNoCurrent