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 5 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATESam's West, Incd2a6e22c-1159-c86a-b927-e7ace1d7023f2025-10-24WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEHikma Pharmaceuticals USA Inc.0d9a521b-8314-437c-8c9f-f6188f1134fe2025-10-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack36c0e343-5bd4-447e-8651-c5f44d2ffd7c2025-09-24Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and SalmeterolFLUTICASONE PROPIONATE AND SALMETEROLBryant Ranch Prepackf3bce31d-93f9-4ca6-835e-b16e2d31b6c52025-08-21Warnings, Adverse reactionsExact identifier
application number: NDA208799
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone Propionate and SalmeterolFLUTICASONE PROPIONATE AND SALMETEROLBryant Ranch Prepack038db4da-1448-4603-a34d-2efd9059811b2025-08-21Warnings, Adverse reactionsExact identifier
application number: NDA208799
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Childrens NasoproFLUTICASONE PROPIONATEH E B607d0a22-72d1-440f-9dac-e088b68dde092025-08-11WarningsExact identifier
unii: O2GMZ0LF5W
ADVAIR HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEA-S Medication Solutions80b36523-4ae4-463e-b1fd-b929fb802b762025-08-08Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Allergy Relief NasalALLERGY RELIEF NASALMarc Glassman, Inc.bf100c3f-b1f4-4efa-af88-b51ed2a217712025-08-08WarningsExact identifier
unii: O2GMZ0LF5W
ADVAIR HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEA-S Medication Solutions223fd5d4-3bd2-4e45-b72e-699438c322062025-08-08Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions17dd0a86-8161-4aa9-9b90-a23d81b381642025-08-08Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
FLUTICAREFLUTICASONE PROPIONATEINNOVUS PHARMACEUTICALS, INC.fed545ab-6a85-4ce3-8651-370e279db49e2025-07-16WarningsExact identifier
unii: O2GMZ0LF5W
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c02025-07-08Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEWalmart8616944c-a684-085a-7106-cf034e3f6f4d2025-07-01WarningsExact identifier
unii: O2GMZ0LF5W
DG Health childrens allergy relief nasalFLUTICASONE PROPIONATEDolgencorp Inc4dc4b47a-233c-4bb8-b08b-c07561c415ff2025-06-03WarningsExact identifier
unii: O2GMZ0LF5W
basic care childrens allergy relief nasalFLUTICASONE PROPIONATEAmazon.com Services LLCcb4cb80a-9bc5-4e7b-a33b-fb462abf96c52025-05-23WarningsExact identifier
unii: O2GMZ0LF5W
fluticasone propionate and salmeterolFLUTICASONE PROPIONATE AND SALMETEROLPreferred Pharmaceuticals Inc.0dea4818-e9d6-42f2-a702-90419fff26952025-05-16Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
fluticasone propionate and salmeterolFLUTICASONE PROPIONATE AND SALMETEROLPreferred Pharmaceuticals Inc.08870f40-8c46-4d91-a101-c3cbb894ca492025-05-14Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATETWIN MED LLC9337aa4b-382d-4ab9-b312-60417cdd40cf2025-05-01WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEAsclemed USA, Inc.6e2d11f9-94d8-4434-b46b-8e2fcc9276fb2025-04-19Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and SalmeterolFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions77269609-fb89-47c7-97cc-22e0183e91ae2025-04-02Warnings, Adverse reactionsExact identifier
application number: NDA208799
rxcui: 1918194
unii: 6EW8Q962A5
unii: O2GMZ0LF5W

Reported adverse events (FAERS/openFDA)#

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