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 6 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATEBryant Ranch Prepacke95227ff-5747-4a35-a1b8-b1019fe1e61c2025-03-31Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATEBryant Ranch Prepack1a930a09-db26-40aa-bb05-123a0d7182bc2025-03-27Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Wixela InhubFLUTICASONE PROPIONATE AND SALMETEROLBryant Ranch Prepack6a5e28ef-3bbb-43a6-b599-499b3c6076c92025-02-13Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltd625ffdd0-8486-49af-8e77-6aa663be5ac72025-01-31Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATERedPharm Drug, Incf4c26992-c988-e20f-e053-2a95a90afb652025-01-23WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEAsclemed USA, Inc.504397c5-6f9f-45cc-9cc9-997da0a803642025-01-15Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Azelastine Hydrochloride and Fluticasone PropionateAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATETeva Pharmaceuticals, Inc.0d45e7a4-900f-44ef-bb18-a1fbff75a3c62025-01-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLCb6134ba0-b70a-4eac-9a82-cef64b242c1d2024-12-19WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEQuality Care Products, LLC1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e2024-12-18Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
allergy nasalFLUTICASONE PROPIONATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED2aee623c-602a-407c-b7a3-e29928d7dfed2024-12-18WarningsExact identifier
unii: O2GMZ0LF5W
Azelastine Hydrochloride and Fluticasone PropionateAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEMylan Pharmaceuticals Inc.7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e2024-12-15Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
fluticasone propionate and salmeterolFLUTICASONE PROPIONATE AND SALMETEROLHikma Pharmaceuticals USA Inc.f9fcfc90-3677-4a9b-900e-44417d50d5072024-12-05Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
DYMISTAAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEViatris Specialty LLC4c557ec4-c4cf-11df-851a-0800200c9a662024-12-04Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEA-S Medication Solutions3b1849e1-bd0b-42e4-a4ac-f156dc18604a2024-11-06Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate HFAFLUTICASONE PROPIONATEA-S Medication Solutionsfaaa1436-dafb-4f65-b062-b51b902f43c52024-10-29Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEProficient Rx LP1d5d5f27-6565-4e7b-9923-faa3d15cb1c42024-10-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEProficient Rx LPab8c172b-c369-4372-95f9-dd1a28b3982b2024-10-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
FluticasoneFLUTICASONE PROPIONATENuCare Pharmaceuticals,Inc.549ff4f2-fa68-3dd8-e054-00144ff8d46c2024-07-15Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATENuCare Pharmaceuticals,Inc.8761a5e1-a9cb-0622-e053-2a95a90a35042024-06-14Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
CHILDRENS ALLERGYFLUTICASONE PROPIONATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDb9b3efe4-2f5c-4d22-80a4-d15fb266fb232024-06-12WarningsExact identifier
unii: O2GMZ0LF5W

Reported adverse events (FAERS/openFDA)#

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