FDA.reportPublic FDA data

NDC 65729-384 - Desloratadine

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
65729-384
Package NDCs from labels
65729-384-02
Manufacturer
Anesta Corporation
Effective date
2016-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Desloratadine - Anesta CorporationAnesta Corporation2016-05-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65729-384-022020-10-20C16284748780-19d75b9d1-1c4d-f424-e053-dadaa90a57ceDesloratadine Orally disintegrating tablet
65729-384-022020-01-31C16284748780-19d75b9d1-1c4d-f424-e053-dadaa90a57ceDesloratadine Orally disintegrating tablet

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESLORATADINEACTIVE INGREDIENTFVF865388RDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
DESLORATADINEACTIVE MOIETYFVF865388RDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1DESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDESLORATADINE TABLET, ORALLY DISINTEGRATING [ANESTA CORPORATION]1

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 41 of 47 · 938 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sodium BicarbonateSODIUM BICARBONATEOMNIVIUM PHARMACEUTICALS LLC.aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc2023-08-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
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
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,c6b5f808-4a49-1303-9711-badb022ecd702023-07-19WarningsExact identifier
unii: 8MDF5V39QO
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
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
SiliceaSILICON DIOXIDEBoironce6a0710-7c28-11e6-86bf-424c583030312023-07-11Exact identifier
unii: ETJ7Z6XBU4
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.4f82e261-6101-48ab-b161-ded5aa41cd852023-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutions619cb558-84e5-43ea-91e9-28c764f9f9c02023-06-21Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions7a2d8dab-750f-43c1-933c-4169a840c60c2023-06-20Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CalciforceARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICABioActive Nutritional, Inc.1609ce3e-82c2-4597-86e6-847c944ddbe62023-06-07WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICEA 6XTrue Botanica, LLCfd296871-c491-7d30-e053-6294a90ab64d2023-06-02WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCb620938d-ab2d-0934-e053-2a95a90a84832023-05-23Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCd1636b56-ad83-4439-e053-2a95a90a135e2023-05-02Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: ETJ7Z6XBU4
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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