FDA.reportPublic FDA data

NDC 70518-4348-00 - Fluticasone Propionate and Salmeterol DISKUS

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
70518-4348
Requested NDC
70518-4348-00
Package NDCs from labels
70518-4348-0, 70518-4348-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluticasone Propionate and Salmeterol DISKUS - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4348-0Fluticasone Propionate and SalmeterolDISKUS1 in 1 CARTONPOWDER11
70518-4348-0Fluticasone Propionate and SalmeterolDISKUS60 in 1 INHALERPOWDER601

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 8 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEA-S Medication Solutions64d669da-559c-40f5-b649-2ce164c211ea2024-01-30Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions9e237635-6975-4930-9ce1-051d9e3bf6152024-01-22Warnings, Adverse reactionsExact identifier
application number: NDA021077
rxcui: 896209
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEA-S Medication Solutions4a4b7242-1083-4912-a318-25c3914aaf222024-01-11Adverse reactionsExact identifier
unii: O2GMZ0LF5W
FLOVENT DISKUSFLUTICASONE PROPIONATEA-S Medication Solutions038e6c40-9421-40ef-874b-8f4d7110a74a2024-01-11Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: J2B2A4N98G
Fluticasone Propionate HFAFLUTICASONE PROPIONATEA-S Medication Solutions674b1c81-359d-4fc4-8ce6-a53931b171e02024-01-02Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
FLOVENT HFAFLUTICASONE PROPIONATEA-S Medication Solutions74563f7b-8512-4b76-8c55-b88b9cd3206b2023-12-09Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltd16985600-3f81-4d51-8bf7-0cbbd89856a12023-11-30Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healtha4e1c265-5205-4089-8190-0755ede838962023-11-28WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATECosette Pharmaceuticals, Inc.e7ef2aaf-749c-66c9-2bdf-7214ab00060e2023-11-22Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate HFAFLUTICASONE PROPIONATEA-S Medication Solutions4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d2023-11-17Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: J2B2A4N98G
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: J2B2A4N98G
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: J2B2A4N98G
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLPrasco Laboratories6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc2023-07-19Warnings, Adverse reactionsExact identifier
application number: NDA021077
ndc (product): 66993-586
rxcui: 896184
rxcui: 896228
rxcui: 896209
spl id: 0f7962ea-0394-4fb8-accd-c0023c7753db
spl set id: 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack8bd6f3a4-87f7-449e-8fcc-fec1537fcab32023-07-17Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack0120296b-bebc-4a2d-8058-6caf41f96e522023-07-17Adverse reactionsExact identifier
unii: O2GMZ0LF5W
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutionsa6d87760-4744-41d5-bfee-db3b996b72942023-05-16Warnings, Adverse reactionsExact identifier
application number: NDA021077
rxcui: 896209
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEA-S Medication Solutionse2df3810-3b92-4678-8f62-683c656b1de92023-04-16Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: J2B2A4N98G

Reported adverse events (FAERS/openFDA)#

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