FDA.reportPublic FDA data

NDC 49771-002-01 - Mitosol

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
49771-002
Requested NDC
49771-002-01
Package NDCs from labels
49771-002-01, 49771-002-03
Manufacturer
Mobius Therapeutics LLC
Effective date
2025-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mitosol - Mobius Therapeutics LLCMobius Therapeutics LLC2025-04-23HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49771-002-01Mitosol1 in 1 TRAYKIT110
49771-002-03Mitosol3 in 1 CARTONKIT310

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49771-002MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]10Current NDC, Legacy NDC, 2 package rows20250423_244002c6-c61d-43fe-9326-072797113979.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49771-002-01EA - Each49771-002cb571edc-741e-43e9-8fbb-232ee4982cc712012-07-24
49771-002-03EA - Each49771-002867c011f-739b-48b4-ac43-e71cd6e0586412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]3
MitomycinACTIVE INGREDIENT50SG953SK6MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]3
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]3
MitomycinACTIVE MOIETY50SG953SK6MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]3
mannitolINACTIVE INGREDIENT3OWL53L36AMITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]3
waterINACTIVE INGREDIENT059QF0KO0RMITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC]3

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 10 · 191 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MITOMYCINMITOMYCINMeitheal Pharmaceuticals Inc.eae9a8bc-84ec-4303-bc43-f656a5ce0fb72021-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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