FDA.reportPublic FDA data

Lotensin HCT

Product NDC
30698-454
11-digit product format
306980454
Labeler code
30698
Product ID
30698-454_4b9222f7-7b31-4781-e063-6394a90ab188
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benazepril hydrochloride and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA020033
Marketing category
NDA
Marketing start
1992-05-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Lotensin HCT
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T, 0J48LPH2TH
Rxcui898362, 898366, 898367, 898371, 898372, 898376

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30698-454-012025-09-30C16284748780-1f386c649-e1b5-0266-e053-dadaa90a7c1aLotensin HCT
30698-454-012025-01-30C16284748780-1f386c649-e1b5-0266-e053-dadaa90a7c1aLotensin HCT
30698-454-012023-02-17C16284748780-1f386c649-e1b5-0266-e053-dadaa90a7c1aLotensin HCT
30698-454-012023-01-30C16284748780-1f386c649-e1b5-0266-e053-dadaa90a7c1aLotensin HCT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-454-01Lotensin HCT100 in 1 BOTTLETABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-454-01EA - Each30698-4546ec4eb6e-ede5-4df5-9873-c6076478caa912014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TLOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
BENAZEPRILATACTIVE MOIETYJRM708L703LOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYLOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-454LOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 1 package rows20231110_94c4536f-e28e-48b1-8336-b3939917e99d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898362benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN94c4536f-e28e-48b1-8336-b3939917e99d15
898367benazepril HCl 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN94c4536f-e28e-48b1-8336-b3939917e99d15
898372benazepril HCl 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN94c4536f-e28e-48b1-8336-b3939917e99d15
898366Lotensin HCT 10 MG / 12.5 MG Oral TabletPSN94c4536f-e28e-48b1-8336-b3939917e99d15
898371Lotensin HCT 20 MG / 12.5 MG Oral TabletPSN94c4536f-e28e-48b1-8336-b3939917e99d15
898376Lotensin HCT 20 MG / 25 MG Oral TabletPSN94c4536f-e28e-48b1-8336-b3939917e99d15
898366benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Lotensin HCT]SBD94c4536f-e28e-48b1-8336-b3939917e99d15
898371benazepril hydrochloride 20 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Lotensin HCT]SBD94c4536f-e28e-48b1-8336-b3939917e99d15
898376benazepril hydrochloride 20 MG / hydrochlorothiazide 25 MG Oral Tablet [Lotensin HCT]SBD94c4536f-e28e-48b1-8336-b3939917e99d15
898362benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD94c4536f-e28e-48b1-8336-b3939917e99d15
898367benazepril hydrochloride 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD94c4536f-e28e-48b1-8336-b3939917e99d15
898372benazepril hydrochloride 20 MG / hydrochlorothiazide 25 MG Oral TabletSCD94c4536f-e28e-48b1-8336-b3939917e99d15
898362benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898367benazepril hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898372benazepril hydrochloride 20 MG / HCTZ 25 MG Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898362BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898366BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral Tablet [Lotensin HCT]SY94c4536f-e28e-48b1-8336-b3939917e99d15
898367BZP hydrochloride 20 MG / HCTZ 12.5 MG Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898371BZP hydrochloride 20 MG / HCTZ 12.5 MG Oral Tablet [Lotensin HCT]SY94c4536f-e28e-48b1-8336-b3939917e99d15
898372BZP hydrochloride 20 MG / HCTZ 25 MG Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898376BZP hydrochloride 20 MG / HCTZ 25 MG Oral Tablet [Lotensin HCT]SY94c4536f-e28e-48b1-8336-b3939917e99d15
898371Lotensin HCT (benazepril HCl 20 MG / HCTZ 12.5 MG) Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898376Lotensin HCT (benazepril HCl 20 MG / HCTZ 25 MG) Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898366Lotensin HCT 10/12.5 (benazepril HCl / HCTZ) Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898366Lotensin HCT 10/12.5 Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898371Lotensin HCT 20/12.5 Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15
898376Lotensin HCT 20/25 Oral TabletSY94c4536f-e28e-48b1-8336-b3939917e99d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30698-454-0130698045401100 TABLET in 1 BOTTLE (30698-454-01) 100 tablet1992-05-300000-00-00NoNoCurrent