FDA.reportPublic FDA data

NDC 60505-0833-05 - 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
60505-0833
Requested NDC
60505-0833-05
Package NDCs from labels
60505-0833-5, 60505-0833-05
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 - Apotex Corp.Apotex Corp.2026-09-08HUMAN PRESCRIPTION DRUG LABEL
Azelastine Hydrochloride - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2025-11-17HUMAN PRESCRIPTION DRUG LABEL
Azelastine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2025-11-06HUMAN PRESCRIPTION DRUG LABEL
Azelastine Hydrochloride - Proficient Rx LPProficient Rx LP2023-10-01HUMAN PRESCRIPTION DRUG LABEL
Azelastine Hydrochloride - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Azelastine Hydrochloride - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-08-09HUMAN PRESCRIPTION DRUG LABEL
Azelastine Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-02-25Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0833-5Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED113
60505-0833-5Azelastine Hydrochloride200 in 1 BOTTLE, SPRAYSPRAY, METERED20013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0833AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]12Current NDC, Legacy NDC, 2 package rows20240920_4f58c203-f649-a18e-aaf3-70b0797652f4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0833-5ML - Milliliter60505-08338a8f4a0e-d9cf-42cf-899c-28a38531a8b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZELASTINE HYDROCHLORIDEACTIVE INGREDIENT0L591QR10IAZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
AZELASTINEACTIVE MOIETYZQI909440XAZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XAZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
WATERINACTIVE INGREDIENT059QF0KO0RAZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]4
azelastine hydrochlorideACTIVE INGREDIENT0L591QR10IAZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
azelastineACTIVE MOIETYZQI909440XAZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XAZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]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 122 · 2,440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
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
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEApotex Corp.4f58c203-f649-a18e-aaf3-70b0797652f42026-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA077954
ndc (package): 60505-0833-5
ndc (product): 60505-0833
ndc11 (package): 60505083305
rxcui: 1797867
spl id: 1609cf10-ae35-1f3e-0d03-3d7caa05a1ad
spl set id: 4f58c203-f649-a18e-aaf3-70b0797652f4
unii: 0L591QR10I
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEApotex Corp.77a33738-ffcf-221c-1562-780418882e5d2026-09-08Warnings, Adverse reactionsExact identifier
unii: 0L591QR10I
Azelastine hydrochloride and Fluticasone propionateAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEApotex Corp.7bbc6514-bea3-0be0-e673-a8f6069025ff2026-09-08Warnings, Adverse reactionsExact identifier
unii: 0L591QR10I
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
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
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
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
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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