NDC 68180-759-03 - Amlodipine Besylate and Benazepril Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68180-759
Requested NDC
68180-759-03
Package NDCs from labels
68180-759-01, 68180-759-02, 68180-759-03
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2025-10-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMLODIPINE BESYLATE - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-10-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-759-01Amlodipine Besylate and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE10024
68180-759-02Amlodipine Besylate and Benazepril Hydrochloride500 in 1 BOTTLECAPSULE50024
68180-759-03Amlodipine Besylate and Benazepril Hydrochloride1000 in 1 BOTTLECAPSULE100024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-759AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 3 package rows20250418_968c611b-43a7-40f0-9ed3-aa67ee88364b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-759-01EA - Each68180-759788017fe-1e96-4ce1-a933-fee8c996f4a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94EAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8

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 156 · 3,102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.0f253cac-67ac-4b03-b1a8-f2c345938dda2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078466
rxcui: 898346
unii: N1SN99T69T
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.dc206611-5188-40a6-b025-61db41f68a5a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078466
rxcui: 898356
unii: N1SN99T69T
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.2542895b-c8f8-4f21-9e12-f5a7fe17f9052026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 898359
unii: N1SN99T69T
unii: 864V2Q084H
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC5af8493b-2b73-859c-e063-6394a90a46202026-09-08Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINApotex Corp.4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b032026-09-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEGSMS, Incorporated9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf2026-09-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs6efc0ef6-0424-44fc-a9ea-eb30c3b832392026-09-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEREMEDYREPACK INC.57ffeef7-bfa8-4f92-aadc-23cd000226072026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.