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 32 of 42 · 840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd17ef907-7719-4246-8ade-b67afdfaf7872024-03-26Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.ffe96aa1-db66-33e4-e053-6394a90a7e4e2024-03-26Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAmneal Pharmaceuticals NY LLC02f9b562-6f7f-4783-bb0d-67c318073e1c2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
PNEUMOPLEXPLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHURBioActive Nutritional, Inc.d839aea1-7725-40c1-b000-228843f75b932024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.95406534-526e-4bca-b73d-1030623549a32024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
Snore-SootheECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICANewton Laboratories, Inc.140a0bcf-82b3-c430-e063-6294a90ad38f2024-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
DizzyCEREBELLUM (SUIS), BRYONIA (ALBA), PETROLEUM, TABACUM, AMBRA GRISEA, CYCLAMEN EUROPAEUM, NATRUM SALICYLICUM, ARGENTUM NITRICUM, ASARUM CANADENSE, CALCAREA SULPHURICA, CARBONEUM SULPHURATUM, CHININUM SULPHURICUM, COCCULUS INDICUS, CONIUM MACULATUM, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, PIPER METHYSTICUM, SILICEA, THERIDIONDeseret Biologicals, Inc.fdf934f8-7b12-4076-b8fb-00c0959406972024-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
VerARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALISDeseret Biologicals, Inc.b47bdd57-14cd-46e9-a34e-0d8a7c21bda22024-03-12WarningsExact identifier
unii: ETJ7Z6XBU4
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
SpinalmaxBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUMDeseret Biologicals, Inc.6c569331-2167-44bb-ace6-13340e7d8d6a2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC132c078d-7d31-a6f2-e063-6294a90af0952024-03-08Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUMDeseret Biologicals, Inc.81f29472-a2e6-486d-aefd-17135ad410ef2024-03-08WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack52daa759-3327-461a-8cfc-3c6253df91ec2024-03-05Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATETeva Pharmaceuticals, Inc.47edc328-2444-4ca1-a5c1-7c83141e105c2024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.a030afc6-9248-4e6a-a814-bd700c053e5c2024-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
CoughIPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.4a8deb4a-9f26-46a9-8d99-99df36407f222024-02-19WarningsExact identifier
unii: ETJ7Z6XBU4
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepackb404a550-0df4-404a-8d10-c35e197ca3992024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Deseret Biologicals, Inc.6d934960-63c6-4536-bde3-38c26f8083dc2024-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDESEVENE USA0805d866-ce1a-4f54-8a44-83d4902e8c0d2024-01-30WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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