FDA.reportPublic FDA data

NDC 68071-2305-02 - Amlodipine Besylate

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
68071-2305
Requested NDC
68071-2305-02
Package NDCs from labels
68071-2305-9, 68071-2305-2, 68071-2305-6, 68071-2305-02
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-10-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amlodipine Besylate - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-10-05HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-05-24These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
2022-05-24These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
2022-01-28These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
2022-01-28These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2305-2Amlodipine Besylate120 in 1 BOTTLE, PLASTICTABLET1204
68071-2305-9Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2305AMLODIPINE BESYLATE TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240719_b4cc6d7e-923b-e81c-e053-2995a90a0731.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 42 · 837 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
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.0f253cac-67ac-4b03-b1a8-f2c345938dda2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.dc206611-5188-40a6-b025-61db41f68a5a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.2542895b-c8f8-4f21-9e12-f5a7fe17f9052026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC5af8493b-2b73-859c-e063-6394a90a46202026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
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
rxcui: 197361
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs6efc0ef6-0424-44fc-a9ea-eb30c3b832392026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
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
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine BesylateAMLODIPINE BESYLATEQPharma, Inc.5866d1ee-631d-d09e-e063-6294a90abe012026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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