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 9 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltd78e056e2-d39e-4d20-9ab2-332bd69736192022-12-30Adverse reactionsExact identifier
unii: O2GMZ0LF5W
topcare fluticasone propionate nasalFLUTICASONE PROPIONATETopco Associates LLCf7c425d2-4afb-478f-83bc-eb336910233b2022-11-01WarningsExact identifier
unii: O2GMZ0LF5W
equate allergy reliefFLUTICASONE PROPIONATEWal-Mart Stores Inc959167e8-f4a1-49b9-b3a6-f0d0b3d7d4772022-10-14WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEAsclemed USA, Inc.75049554-64ca-4efa-b8d1-13cf31d0ff902022-10-12Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
SEREVENT DISKUSSALMETEROL XINAFOATEGlaxoSmithKline LLC12d9728e-6b5c-4aee-bfb0-745e542ed2e42022-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
fluticasone propionate and salmeterolFLUTICASONE PROPIONATE AND SALMETEROLTeva Pharmaceuticals USA, Inc.ce347bf4-4cc1-46dc-b5f1-6f8ff48da84b2022-09-28Warnings, Adverse reactionsExact identifier
rxcui: 896184
rxcui: 896228
rxcui: 896209
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Wixela InhubFLUTICASONE PROPIONATE AND SALMETEROLMylan Pharmaceuticals Inc.3beef422-8a07-4a45-9ba6-414511e4b7e22022-08-29Warnings, Adverse reactionsExact identifier
rxcui: 896184
rxcui: 896228
rxcui: 896209
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Saccharum LactisSACCHARUM LACTISHahnemann Laboratories, INC.e6f02163-2845-680d-e053-2a95a90ae43a2022-08-23Exact identifier
unii: J2B2A4N98G
Fluticasone PropionateFLUTICASONE PROPIONATECosette Pharmaceuticals, Inc.14c8d082-b301-8f09-a509-950459ae0a282022-05-05Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: J2B2A4N98G
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: J2B2A4N98G
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: J2B2A4N98G
Fluticasone PropionateFLUTICASONE PROPIONATEGlenmark Pharmaceuticals Inc., USA3c7b3482-e2fd-4857-9394-a47fd7f4c47b2020-02-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLProficient Rx LP6915bd5d-b792-4b1b-8221-7eeb0a8638ba2020-01-01Warnings, Adverse reactionsExact identifier
application number: NDA021077
rxcui: 896209
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEProficient Rx LP96af29b8-16b4-4113-9ec3-338438e11a492019-11-01Adverse reactionsExact identifier
unii: O2GMZ0LF5W
FLOVENT DISKUSFLUTICASONE PROPIONATEProficient Rx LP816e929e-6ba0-437d-80bb-00068419ed532019-11-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATESelder, S.A. de C.V.2da4ba91-c356-473d-b20c-5bb9265767df2017-11-29WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Health4e1cd546-4598-115b-0357-5d0c22731faa2017-11-17WarningsExact identifier
unii: O2GMZ0LF5W

Reported adverse events (FAERS/openFDA)#

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