FDA.reportPublic FDA data

NDC 63629-8809-01 - Fluticasone Propionate and Salmeterol

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
63629-8809
Requested NDC
63629-8809-01
Package NDCs from labels
63629-8809-1, 63629-8809-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluticasone Propionate and Salmeterol - Bryant Ranch PrepackBryant Ranch Prepack2024-04-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8809-1Fluticasone Propionate and Salmeterol1 in 1 POUCHPOWDER, METERED1103
63629-8809-1Fluticasone Propionate and Salmeterol1 in 1 CARTONPOWDER, METERED1103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8809FLUTICASONE PROPIONATE AND SALMETEROL POWDER, METERED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240504_84654ac7-e2b4-4fa1-b127-69aee03aecc0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8809-1EA - Each63629-8809098c77b1-bde7-4358-9873-db2d92a5fcc912021-12-08

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 8 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLPrasco Laboratories6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc2023-07-19Warnings, Adverse reactionsExact identifier
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
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEA-S Medication Solutionse2df3810-3b92-4678-8f62-683c656b1de92023-04-16Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
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
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Wixela InhubFLUTICASONE PROPIONATE AND SALMETEROLMylan Pharmaceuticals Inc.3beef422-8a07-4a45-9ba6-414511e4b7e22022-08-29Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATECosette Pharmaceuticals, Inc.14c8d082-b301-8f09-a509-950459ae0a282022-05-05Adverse reactionsExact identifier
unii: O2GMZ0LF5W
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
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

Reported adverse events (FAERS/openFDA)#

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