FDA.reportPublic FDA data

NDC 70518-1971-01 - 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
70518-1971
Requested NDC
70518-1971-01
Package NDCs from labels
70518-1971-0, 70518-1971-1, 70518-1971-2, 70518-1971-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amlodipine Besylate - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1971-0Amlodipine Besylate30 in 1 BLISTER PACKTABLET3014
70518-1971-1Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET9014
70518-1971-2Amlodipine Besylate30 in 1 BLISTER PACKTABLET3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1971AMLODIPINE BESYLATE TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250511_4ad016ec-e158-4325-9f45-4460cf78dd98.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1971-0EA - Each70518-1971c914214d-b7d1-42e8-88eb-9955aafee09912026-01-08
70518-1971-1EA - Each70518-1971477430ff-6024-4678-abab-fc2f71919d3512026-01-08

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 35 of 42 · 840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions4512feee-a09d-4244-bc03-c43193e53a0e2023-09-20Warnings, Adverse reactionsExact identifier
application number: ANDA078925
rxcui: 197361
unii: 864V2Q084H
Stomach DistressBISMUTHUM SUBNITRICUM, CALCAREA SULPHURICA, CARBO ANIMALIS, CARBO VEGETABILIS, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, NUX VOMICA, ORNITHOGALUM UMBELLATUM, PYROGENIUM, SILICEA,Liddell Laboratories, Inc.4c764fbe-2fbf-4f06-9ad5-824373c6929a2023-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsf77db79c-c998-4b63-9984-4cf245f188a72023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee12023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: ETJ7Z6XBU4
MEB Puri-vegaMEB PURI-VEGAKadesh Incoporation Co,Ltd03865989-3034-10fc-e063-6394a90ac80b2023-09-05WarningsExact identifier
unii: ETJ7Z6XBU4
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate IICOFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.2d3657d9-d4f4-426c-b381-dbfde9b8e2cd2023-09-01WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions69a887ab-95cd-4b81-80ee-02e20eebf65b2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
BABY MUCUS PLUS COLD RELIEFBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.d934cc8a-1e43-4942-858a-05b5d068679a2023-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.8b1414d5-57d8-46d5-b4be-3011429bdd0d2023-08-21WarningsExact identifier
unii: ETJ7Z6XBU4
PituistatARALIA QUINQUEFOLIA, GINKGO BILOBA, ARSENICUM IODATUM, AVENA SATIVA, BARYTA CARBONICA, PHOSPHORUS, SILICEA, THYROIDINUM (SUIS), ALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUMEnergique, Inc.27a5fccb-8707-4bb5-a848-d1921bba2f7f2023-08-21WarningsExact identifier
unii: ETJ7Z6XBU4
CellergyCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.Ratis, LLC2aebc11e-eeb7-436b-b90c-3a2f59fb74922023-08-07WarningsExact identifier
unii: ETJ7Z6XBU4
MEB Puri-MegaMEB PURI-MEGAKadesh Incoporation Co,Ltd018125f2-ad4b-b38a-e063-6294a90a7f6e2023-07-27WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.c100d87b-4d67-42ef-b7e2-fd3642a104b82023-07-18WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICEARatis, LLC8c2b59e1-9936-486c-9a91-153e46f377e62023-07-13WarningsExact identifier
unii: ETJ7Z6XBU4
AzorAMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMILCosette Pharmaceuticals, Inc.c5535406-b63b-49aa-88b9-169aaf0ed08e2023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
TribenzorOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.2f56d0bc-236b-41a0-9fc0-21cdfea8d8902023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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