FDA.reportPublic FDA data

Benazepril Hydrochloride and Hydrochlorothiazide

Product NDC
0185-0211
11-digit product format
001850211
Labeler code
0185
Product ID
0185-0211_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
2004-02-11
Substance
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength
20; 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 HYDROCHLORIDE20 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, N1SN99T69T
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
0185-0211-01Benazepril 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
0185-0211-01EA - Each0185-0211acee257d-9966-4b66-bd6b-3af478313d4b12012-07-24

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
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0211BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]31Current NDC, Legacy NDC, 1 package rows20240320_c9bdfbb4-87b6-4de4-bc1d-5025d3ef591f.zip

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
898362benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898367benazepril HCl 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898372benazepril HCl 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898362benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898367benazepril hydrochloride 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898372benazepril hydrochloride 20 MG / hydrochlorothiazide 25 MG Oral TabletSCDabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898362benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSYabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898367benazepril hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSYabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898372benazepril hydrochloride 20 MG / HCTZ 25 MG Oral TabletSYabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898362BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSYabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898367BZP hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSYabc87aa0-77f3-441e-96a5-0f0bc4e8afd03
898372BZP hydrochloride 20 MG / HCTZ 25 MG Oral TabletSYabc87aa0-77f3-441e-96a5-0f0bc4e8afd03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-0211-0100185021101100 TABLET, FILM COATED in 1 BOTTLE (0185-0211-01) 2004-02-110000-00-00NoNoCurrent