Benazepril Hydrochloride and Hydrochlorothiazide

Product NDC
68462-577
11-digit product format
684620577
Labeler code
68462
Product ID
68462-577_51b0aed8-a229-4d2c-8fdf-aa957fddc41b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
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

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 Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T, 0J48LPH2TH
Rxcui898362, 898367, 898372, 898378

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
68462-577-01Benazepril Hydrochloride and Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-577BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]1Current NDC, 1 package rows20231202_51b0aed8-a229-4d2c-8fdf-aa957fddc41b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898362benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898367benazepril HCl 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898372benazepril HCl 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898378benazepril HCl 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898362benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898367benazepril hydrochloride 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898372benazepril hydrochloride 20 MG / hydrochlorothiazide 25 MG Oral TabletSCD51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898378benazepril hydrochloride 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898362benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898367benazepril hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898372benazepril hydrochloride 20 MG / HCTZ 25 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898378benazepril hydrochloride 5 MG / HCTZ 6.25 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898362BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898367BZP hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898372BZP hydrochloride 20 MG / HCTZ 25 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1
898378BZP hydrochloride 5 MG / HCTZ 6.25 MG Oral TabletSY51b0aed8-a229-4d2c-8fdf-aa957fddc41b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68462-577-0168462057701100 TABLET, FILM COATED in 1 BOTTLE (68462-577-01) 2023-12-01NoNoCurrent