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 10 of 19 · 363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
budesonideBUDESONIDEMajor Pharmaceuticalse7aca8d1-159e-4aac-b92d-3a69a8edceec2025-03-10Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
budesonideBUDESONIDENorthstar Rx LLC.a37866df-df07-4f71-8591-98c2804c47942025-02-18Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
budesonideBUDESONIDEZydus Pharmaceuticals USA Inc.29863154-5f98-410e-9bf3-0f08b551edef2025-02-12Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
budesonideBUDESONIDEZydus Lifesciences Limitedd645a346-c99b-4de7-9bca-69e73266d6b42025-02-12Exact identifier
unii: Q3OKS62Q6X
Budesonide Inhalation SuspensionBUDESONIDEPreferred Pharmaceuticals Inc.dcb35488-23c5-4e7b-ab86-8406cf8557482025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
BudesonideBUDESONIDEA-S Medication Solutionsd406759d-4c02-4fc0-b513-56b303afca982025-02-06Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
EohiliaBUDESONIDETAKEDA PHARMACEUTICALS AMERICA, INC.56f2023a-69b2-4470-b4ad-af7ec1be527a2025-02-03Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
budesonide inhalationBUDESONIDE INHALATIONLupin Pharmaceuticals, Inc.944cbb7c-b41d-4a6d-8a93-2e646365c9822025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 2968PHW8QP
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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