benazepril hydrochloride and hydrochlorothiazide

Product NDC
72888-222
11-digit product format
728880222
Labeler code
72888
Product ID
72888-222_4b924079-c490-67c8-e063-6394a90aa7d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benazepril hydrochloride and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
NDA020033
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-12-05
Substance
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength
20; 25 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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
N020033-001LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-19
N020033-002LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALABRLD1992-05-19
N020033-003LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALABRLD1992-05-19
N020033-004LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRLD1992-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020033-002AB
N020033-003AB
N020033-004AB

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 22:38:342026-08N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD1992-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-1984e616aacf4f…
2026-08-18 06:07:402026-07N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD1992-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD1992-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD, RS1992-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD, RS1992-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD, RS1992-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD, RS1992-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD, RS1992-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD, RS1992-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020033-001LOTENSIN HCT5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020033-002LOTENSIN HCT10MG;12.5MGTABLET / ORALABRLD1992-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020033-003LOTENSIN HCT20MG;25MGTABLET / ORALABRLD, RS1992-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020033-004LOTENSIN HCT20MG;12.5MGTABLET / ORALABRLD1992-05-195bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020033-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020033-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020033-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N020033-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020033-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020033-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020033-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020033-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020033-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020033-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020033-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020033-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020033-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020033-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020033-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020033-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020033-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020033-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020033-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020033-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020033-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020033-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020033-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020033-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020033-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020033-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020033-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020033-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020033-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020033-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020033-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020033-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020033-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020033-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020033-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020033-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020033-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020033-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020033-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020033-002AB1301d65b070ca…

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 and hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE20 mg/1
HYDROCHLOROTHIAZIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup
N1SN99T69TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898362Internal RxNorm lookup
898367Internal RxNorm lookup
898372Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f6e6da8-6da3-47c5-a151-e6fd7206890eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-222-01benazepril hydrochloride and hydrochlorothiazide100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-222-01EA - Each72888-222880639f4-97d2-4150-ac0a-8642922bb7db12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-222BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [ADVAGEN PHARMA LTD]1Current NDC, 1 package rows20241208_3f6e6da8-6da3-47c5-a151-e6fd7206890e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotensin HCTBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEValidus Pharmaceuticals LLC94c4536f-e28e-48b1-8336-b3939917e99d2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020033
application number: NDA020033
benazepril hydrochloride and hydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEAdvagen Pharma Ltd3f6e6da8-6da3-47c5-a151-e6fd7206890e2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020033
application number: NDA020033
ndc (product): 72888-222
benazepril hydrochloride and hydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf4120568-dd9b-47a5-bd44-4de6ed343bbe2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020033
application number: NDA020033
benazepril hydrochloride and hydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPadagis US LLC3e2d3974-38b0-49d0-8020-f741075847242023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020033
application number: NDA020033

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898362benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898367benazepril HCl 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898372benazepril HCl 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898362benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898367benazepril hydrochloride 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898372benazepril hydrochloride 20 MG / hydrochlorothiazide 25 MG Oral TabletSCD3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898362benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898367benazepril hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSY3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898372benazepril hydrochloride 20 MG / HCTZ 25 MG Oral TabletSY3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898362BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898367BZP hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSY3f6e6da8-6da3-47c5-a151-e6fd7206890e3
898372BZP hydrochloride 20 MG / HCTZ 25 MG Oral TabletSY3f6e6da8-6da3-47c5-a151-e6fd7206890e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-222-0172888022201100 TABLET in 1 BOTTLE (72888-222-01) 100 tablet2024-12-05NoNoCurrent