FDA.reportPublic FDA data

NDC 45802-627-01 - BUDESONIDE

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
45802-627
Requested NDC
45802-627-01
Package NDCs from labels
45802-627-01, 45802-627-86
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2023-04-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUDESONIDE - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2023-04-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-627-01BUDESONIDE1 in 1 CANISTERAEROSOL, FOAM11
45802-627-86BUDESONIDE2 in 1 CARTONAEROSOL, FOAM21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-627BUDESONIDE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]1Current NDC, 2 package rows20230418_ad4a68e7-9200-4f05-8058-714d5d8900f8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-627-01GM - Gram45802-6273ef56ac0-519e-43ad-99c1-95fcfc24262112023-05-05
45802-627-86GM - Gram45802-627549bb7d9-5f26-4c22-9199-11f3d41d173912023-05-05

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 4 of 19 · 363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCa645756c-c692-4bc6-a858-7e7e249561bd2026-03-12Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDEAmerican Health Packaging4a8e79df-3946-4e9a-b214-e9fdd824b5652026-03-09Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
BudesonideBUDESONIDERugby Laboratories04eb9e98-1323-353f-3fd7-2d317dfac5262026-02-27WarningsExact identifier
unii: Q3OKS62Q6X
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
budesonideBUDESONIDEBryant Ranch Prepack33def4dc-b469-f987-e063-6294a90ace0b2026-02-17Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Budesonide InhalationBUDESONIDEAmneal Pharmaceuticals of New York LLCe8ef9489-83a2-4817-b21c-ea3fecd8c8dd2026-02-02Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
PULMICORT FLEXHALERBUDESONIDEA-S Medication Solutions5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662026-01-29Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
TarpeyoBUDESONIDECalliditas Therapeutics AB938cada4-d6bf-4252-836f-dd40f9eadb4d2026-01-21Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDEWalgreens9d519bf3-8d9b-5208-13c5-308edc24aca72026-01-21WarningsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDECVS Pharmacyb2650d29-c011-48f1-a7f4-040011d4563d2026-01-21WarningsExact identifier
unii: Q3OKS62Q6X
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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