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 3 of 19 · 363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
budesonideBUDESONIDEREMEDYREPACK INC.5e39c491-2793-410e-b77f-8b3cbe9b62312026-05-21Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
BudesonideBUDESONIDEAmerican Health Packagingc7df2a10-4166-423e-bb60-5f3a8234f26c2026-05-18Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
BREZTRIBUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATEAstraZeneca Pharmaceuticals LP715433dc-cb2b-43ea-b6df-c5b4177adc6c2026-04-27Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Budesonide and Formoterol Fumarate DihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCd6cc66c9-6f97-4ea8-a787-30a048004c772026-04-24Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDECardinal Health 107, LLC3e8a6cf4-4bda-4e22-8653-12635adfb3162026-04-14Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDESun Pharmaceutical Industries, Inc.a39fbcfc-3ffd-44bd-b882-01f8e18442132026-04-14Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Budesonide InhalationBUDESONIDEPreferred Pharmaceuticals Inc.1d139a25-9c17-4b3e-8ffd-b2d562cc00ee2026-03-20Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
budesonide inhalationBUDESONIDE INHALATIONPreferred Pharmaceuticals, Inc.dd74e446-7c1b-4f02-9c73-ba716572ee772026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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