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 7 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone Propionate and Salmeterol HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEPrasco Laboratories666c5b12-a4f7-4c53-8261-4742b5e5a6df2024-05-29Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
ADVAIR HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEGlaxoSmithKline LLCdfaca6f9-3277-47b2-319d-1377917cb54c2024-05-23Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
fluticasone propionateFLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltdc4d361d4-d480-4fb2-8cc7-4cc3e57838dc2024-05-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Health4250d331-17b0-46be-a779-fb4f09bade162024-04-11WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack96e0681d-3788-49cc-8c0e-3185675b8da12024-04-04Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and SalmeterolFLUTICASONE PROPIONATE AND SALMETEROLBryant Ranch Prepack84654ac7-e2b4-4fa1-b127-69aee03aecc02024-04-04Warnings, Adverse reactionsExact identifier
application number: NDA208799
ndc (package): 63629-8809-1
ndc (product): 63629-8809
ndc11 (package): 63629880901
rxcui: 1918194
spl id: 3853b8ad-898f-4783-87b2-8b5952dcaf5e
spl set id: 84654ac7-e2b4-4fa1-b127-69aee03aecc0
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepackaed4ac53-cf6e-489e-bb7e-b8c444e4339e2024-04-04Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepackf6aca9a9-0310-4c11-84b2-eacd19c45a1d2024-04-04Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack8204a0c2-bd24-409a-b848-b3b369df642f2024-03-11Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLCfab7a1f4-75e0-416f-9644-07aff08e6ab02024-03-05WarningsExact identifier
unii: O2GMZ0LF5W
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLC3adff80f-fca7-4cc5-b106-0f68f71c85b02024-02-08WarningsExact identifier
unii: O2GMZ0LF5W
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions7c9c722b-68ac-4bda-ad99-50e3fb1c58c82024-01-30Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
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
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
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

Reported adverse events (FAERS/openFDA)#

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