FDA.reportPublic FDA data

NDC 68071-4251-01 - 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
68071-4251
Requested NDC
68071-4251-01
Package NDCs from labels
68071-4251-3, 68071-4251-6, 68071-4251-9, 68071-4251-1, 68071-4251-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-06
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.2024-06-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4251-32021-02-16These 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
68071-4251-62021-02-16These 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
68071-4251-92021-02-16These 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
68071-4251-32021-01-29These 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
68071-4251-62021-01-29These 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
68071-4251-92021-01-29These 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
68071-4251-1Amlodipine Besylate120 in 1 BOTTLETABLET1206
68071-4251-3Amlodipine Besylate30 in 1 BOTTLETABLET306
68071-4251-6Amlodipine Besylate60 in 1 BOTTLETABLET606
68071-4251-9Amlodipine Besylate90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4251AMLODIPINE BESYLATE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 4 package rows20240608_638d86ab-986b-59ed-e053-2a91aa0a98ee.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 7 of 41 · 816 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepackba6f6ab5-b65a-4486-b994-2d8bbbe650af2026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack5d7ca186-f22b-465f-913b-c020240b2c662026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack50112e22-5a69-47c9-90cd-82bbacae74182026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack9654e50b-811a-4c89-b1ab-f48418b204c12026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca2026-03-09WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackf16e04b5-57b9-49cc-811b-07d85ccb5d9f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Defense 2.0LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine BesylateAMLODIPINE BESYLATELegacy Pharmaceutical Packaging, LLC2cdd0da9-eea6-45e0-b0b7-35413a168a4f2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATELegacy Pharmaceutical Packaging, LLC215ef2cb-d5b6-43d5-bbd5-195ec57cde2b2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAurobindo Pharma Limitedb6f298ba-2d7e-4a3c-9edb-8b60aba716d62026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.b25681a9-7b0e-40f9-844e-ec4842e3713c2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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