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 30 of 42 · 840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mind Detox and DrainageALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUMDeseret Biologicals, Inc.1ac1e955-a374-4cac-b997-51c6aef8d35d2024-08-01WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack3de54c49-3590-4a70-9268-fa68e434d9232024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack30c401b5-decf-4c0c-8180-92a9b3d7d0fb2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: ETJ7Z6XBU4
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackc870013c-e823-4233-a803-33a74f3610a82024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine and ValsartanAMLODIPINE AND VALSARTANAlembic Pharmaceuticals Inc.6894085d-6076-4e2e-8105-a9bbb0bd93ef2024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAscend Laboratories, LLC3f4703c0-0b9e-41a0-8b70-da26683d9ed22024-06-21Warnings, Adverse reactionsExact identifier
application number: ANDA078925
ndc (product): 67877-197
rxcui: 197361
rxcui: 308136
rxcui: 308135
spl id: 9fb4b641-2b16-4bcb-89de-d8d5893916ec
spl set id: 3f4703c0-0b9e-41a0-8b70-da26683d9ed2
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.9c448d87-294e-3325-e053-2a95a90a22992024-06-20Warnings, Adverse reactionsExact identifier
application number: ANDA078925
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited99ed4927-9a34-4e8d-8eea-60b63c867d462024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEDirect_Rx094498f2-11d9-2a05-e063-6294a90ab2e12024-06-13Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5a67bbdc-ac1f-4778-bbdc-929df140b7f52024-06-10Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
SILICEASILICEARxhomeo Private Limited d.b.a. Rxhomeo, Inc1a361030-a925-0998-e063-6394a90a915d2024-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.638d86ab-986b-59ed-e053-2a91aa0a98ee2024-06-06Warnings, Adverse reactionsExact identifier
application number: ANDA078925
rxcui: 197361
unii: 864V2Q084H
Multiple MiasmACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.92c97bf6-8dd9-43a9-b686-75420b0291972024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
OsteoparEQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OLEUM MORRHUAE, SILICEA, HEKLA LAVAEnergique, Inc.6c346a26-26a2-4be0-b8a3-bbb5709bcf3d2024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine and valsartanAMLODIPINE AND VALSARTANAurobindo Pharma Limited7fa25f10-29e0-4162-81a8-9d2e03054ded2024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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