FDA.reportPublic FDA data

NDC 60505-0578-04 - AZELASTINE HYDROCHLORIDE

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
60505-0578
Requested NDC
60505-0578-04
Package NDCs from labels
60505-0578-4, 60505-0578-04
Manufacturer
Apotex Corp.
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 Ophthalmic Solution, USP 0.05%Apotex Corp.2026-09-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0578-4AZELASTINE HYDROCHLORIDE1 in 1 CARTONSOLUTION/ DROPS110
60505-0578-4AZELASTINE HYDROCHLORIDE6 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0578AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]8Current NDC, Legacy NDC, 2 package rows20240920_77a33738-ffcf-221c-1562-780418882e5d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0578-4ML - Milliliter60505-0578f3407113-edf7-4a86-94cd-d7c49baf154512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZELASTINE HYDROCHLORIDEACTIVE INGREDIENT0L591QR10IAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1
AZELASTINEACTIVE MOIETYZQI909440XAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1
SORBITOLINACTIVE INGREDIENT506T60A25RAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]1

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 70 · 1,390 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
North Woods Derma Foam Hand SanitizerBENZALKONIUM CHLORIDESuperior Chemical Corporationad51a175-2b91-fd14-e053-2995a90ad54d2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
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
application number: ANDA078621
ndc (package): 60505-0578-4
ndc (product): 60505-0578
ndc11 (package): 60505057804
rxcui: 860805
spl id: 364ef1af-2b97-d1c6-7469-b76ba5567230
spl set id: 77a33738-ffcf-221c-1562-780418882e5d
unii: 0L591QR10I
Azelastine hydrochloride and Fluticasone propionateAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEApotex Corp.7bbc6514-bea3-0be0-e673-a8f6069025ff2026-09-08Warnings, Adverse reactionsExact identifier
unii: 0L591QR10I
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cd664e-f232-bd50-e063-6394a90ac1392026-09-07WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: F5UM2KM3W7
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
unii: F5UM2KM3W7
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
unii: F5UM2KM3W7
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
unii: F5UM2KM3W7
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Swisher Advanced Antibacterial Foam HandsoapBENZALKONIUM CHLORIDEEcolab Inc.38bd6680-db95-424c-8e84-2e12c2388a732026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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