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 5 of 10 · 191 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
MitosolMITOMYCINMobius Therapeutics LLC244002c6-c61d-43fe-9326-0727971139792025-04-23Warnings, Adverse reactionsExact identifier
application number: NDA022572
ndc (package): 49771-002-01
ndc (package): 49771-002-03
ndc (product): 49771-002
ndc11 (package): 49771000201
rxcui: 1244553
rxcui: 1244558
spl id: ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7
spl set id: 244002c6-c61d-43fe-9326-072797113979
MitomycinMITOMYCINAccord Healthcare, Inc.ff676355-313d-4575-8f2f-e4a1e95274772025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
MUTAMYCINMITOMYCINAccord BioPharma Inc.cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
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
MitomycinMITOMYCINBryant Ranch Prepack799a06b1-7697-42a3-b31a-c9d621b34f6f2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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