FDA.reportPublic FDA data

NDC 60505-0953-03 - Azelastine hydrochloride and Fluticasone propionate

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
60505-0953
Requested NDC
60505-0953-03
Package NDCs from labels
60505-0953-3, 60505-0953-6, 60505-0953-03
Manufacturer
Apotex Corp. | Apotex 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
Azelastine hydrochloride and Fluticasone propionate - Apotex Corp. | Apotex Inc.Apotex Corp. | Apotex Inc.2026-09-08HUMAN PRESCRIPTION DRUG LABEL
Azelastine hydrochloride and Fluticasone propionate - Bryant Ranch PrepackBryant Ranch Prepack2024-10-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0953-3Azelastine hydrochloride and Fluticasone propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED12014
60505-0953-3Azelastine hydrochloride and Fluticasone propionate1 in 1 CARTONSPRAY, METERED114
60505-0953-6Azelastine hydrochloride and Fluticasone propionate60 in 1 BOTTLE, SPRAYSPRAY, METERED6014
60505-0953-6Azelastine hydrochloride and Fluticasone propionate1 in 1 CARTONSPRAY, METERED114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0953AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]14Current NDC, Legacy NDC, 4 package rows20250119_7bbc6514-bea3-0be0-e673-a8f6069025ff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0953-3GM - Gram60505-0953bbaad48c-722e-46bb-b04a-fb88a4de52e612020-04-20

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 1 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEApotex Corp.4f58c203-f649-a18e-aaf3-70b0797652f42026-09-08Warnings, Adverse reactionsExact identifier
unii: 0L591QR10I
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEApotex Corp.77a33738-ffcf-221c-1562-780418882e5d2026-09-08Warnings, Adverse reactionsExact identifier
unii: 0L591QR10I
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.1ce604aa-2535-4a3c-a64d-092f5d4f81942026-09-08Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.197b7628-71aa-4fa2-94df-d617c0f2c9862026-09-08Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Azelastine hydrochloride and Fluticasone propionateAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEApotex Corp.7bbc6514-bea3-0be0-e673-a8f6069025ff2026-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA207712
ndc (package): 60505-0953-3
ndc (package): 60505-0953-6
ndc (product): 60505-0953
ndc11 (package): 60505095303
rxcui: 1797847
spl id: 7497532a-03c9-9016-0df5-6d3acfc3b29b
spl set id: 7bbc6514-bea3-0be0-e673-a8f6069025ff
unii: O2GMZ0LF5W
unii: 0L591QR10I
FluticasoneFLUTICASONE PROPIONATEYYBA CORP535b2575-8af8-d951-e063-6394a90ac72d2026-09-01WarningsExact identifier
unii: O2GMZ0LF5W
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAurohealth LLC7281c597-651e-4425-8208-7637cd9d35002026-08-20WarningsExact identifier
unii: 0L591QR10I
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDECVS PHARMACY, INC22d516d0-da22-4e3b-a4a5-135b009bc9682026-08-19WarningsExact identifier
unii: 0L591QR10I
Fluticasone PropionateFLUTICASONE PROPIONATEGlenmark Pharmaceuticals Inc., USAbc08915f-fa3a-4509-a01c-42b577f39b992026-08-19Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEWalgreens16756136-e813-8a91-3351-7e759d1b4b942026-08-17WarningsExact identifier
unii: O2GMZ0LF5W
TopCare Childrens Allergy Relief Nasal 24 HourFLUTICASONE PROPIONATETopco Associates LLC3eeab9c9-82db-4d03-b4ba-34c1d6f1b1a92026-08-11WarningsExact identifier
unii: O2GMZ0LF5W
CHILDRENS ALLERGY RELIEFFLUTICASONE PROPIONATEWalgreen Company2e81a611-15c2-466e-a111-8ecf939b95602026-08-11WarningsExact identifier
unii: O2GMZ0LF5W
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATEL. Perrigo Company6f3f64e6-d1f8-40d7-bb25-f6f279db99872026-08-11WarningsExact identifier
unii: O2GMZ0LF5W
Equate Allergy ReliefFLUTICASONE PROPIONATEWALMART INC.bc824143-b876-4c3d-86fd-81fb586738512026-08-10WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEGolden State Medical Supply, Inc.534d78c5-4ba0-4ab1-e063-6294a90a8ff72026-08-05Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
ALLERGY RELIEF NASALFLUTICASONE PROPIONATEAmazon.com Services LLCdc552613-5cfe-4de3-b2c0-79703316758a2026-07-30WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEThe Kroger Co.f05689fa-7ff3-0846-c647-bdbe79cb2ff82026-07-29WarningsExact identifier
unii: O2GMZ0LF5W
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATESportpharm LLC348cbd8c-edeb-499c-961d-3aeb5cc2cef12026-07-28Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEYYBA Corp52f67910-11a7-6e7d-e063-6394a90ac9e82026-07-22WarningsExact identifier
unii: 0L591QR10I
Fluticasone PropionateFLUTICASONE PROPIONATE NASALAdvagen Pharma Ltd.0107ad1c-1d8e-434c-a91f-dd2caf4fa5e52026-07-17WarningsExact identifier
unii: O2GMZ0LF5W

Reported adverse events (FAERS/openFDA)#

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