FDA.reportPublic FDA data

Benazepril Hydrochloride and Hydrochlorothiazide

Product NDC
0185-0325
11-digit product format
001850325
Labeler code
0185
Product ID
0185-0325_d9ded9f8-b60e-4325-a813-44b5ee485acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA076631
Marketing category
ANDA
Marketing start
2014-04-04
Substance
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength
10; 12.5 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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11
A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11
A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11
A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALABRS2004-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076631-001AB
A076631-002AB
A076631-003AB
A076631-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALABRS2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076631-001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2004-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076631-002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2004-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076631-003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2004-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076631-004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE20MG;25MGTABLET / ORALAB2004-02-11d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 155 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076631-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076631-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076631-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076631-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076631-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076631-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076631-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076631-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076631-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076631-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076631-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076631-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076631-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076631-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076631-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE10 mg/1
HYDROCHLOROTHIAZIDE12.5 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898362Internal RxNorm lookup
898367Internal RxNorm lookup
898372Internal RxNorm lookup
898378Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9bdfbb4-87b6-4de4-bc1d-5025d3ef591fAvailable 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
0185-0325-01Benazepril Hydrochloride and Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED10032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0325-01EA - Each0185-03252d8ab3f0-e07a-4179-9b31-b28f124c195612014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
TALCINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [EON LABS, INC.]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0325BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]31Current NDC, Legacy NDC, 1 package rows20240320_c9bdfbb4-87b6-4de4-bc1d-5025d3ef591f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDESandoz Incc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f2025-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076631
application number: ANDA076631
ndc (product): 0185-0325
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA51b0aed8-a229-4d2c-8fdf-aa957fddc41b2023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076631
application number: ANDA076631

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898362benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898367benazepril HCl 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898372benazepril HCl 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898378benazepril HCl 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSNc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898362benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898367benazepril hydrochloride 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898372benazepril hydrochloride 20 MG / hydrochlorothiazide 25 MG Oral TabletSCDc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898378benazepril hydrochloride 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCDc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898362benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898367benazepril hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898372benazepril hydrochloride 20 MG / HCTZ 25 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898378benazepril hydrochloride 5 MG / HCTZ 6.25 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898362BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898367BZP hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898372BZP hydrochloride 20 MG / HCTZ 25 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32
898378BZP hydrochloride 5 MG / HCTZ 6.25 MG Oral TabletSYc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-0325-0100185032501100 TABLET, FILM COATED in 1 BOTTLE (0185-0325-01) 2014-04-040000-00-00NoNoCurrent