Mitosol

Product NDC
49771-002
11-digit product format
497710002
Labeler code
49771
Product ID
49771-002_ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mitomycin
Dosage form
KIT
Labeler
Mobius Therapeutics LLC
Application
NDA022572
Marketing category
NDA
Marketing start
2012-02-08
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mitosol
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1244553, 1244558

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61a18a7f-d50a-4423-aa08-6a8f710ed5daProduct name720250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1f4d6d8c-234a-4bf6-b123-695584719ba0Product name120200728
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

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

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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244553mitoMYcin 0.2 MG/ML Ophthalmic SolutionPSN244002c6-c61d-43fe-9326-07279711397910
1244558Mitosol 0.2 MG/ML Ophthalmic SolutionPSN244002c6-c61d-43fe-9326-07279711397910
1244558mitomycin 0.2 MG/ML Ophthalmic Solution [Mitosol]SBD244002c6-c61d-43fe-9326-07279711397910
1244553mitomycin 0.2 MG/ML Ophthalmic SolutionSCD244002c6-c61d-43fe-9326-07279711397910
1244558Mitosol 0.2 MG/ML Ophthalmic SolutionSY244002c6-c61d-43fe-9326-07279711397910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49771-002-01497710002011 in 1 TRAYHistorical
49771-002-03497710002033 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS3 tray2012-02-080000-00-00NoNoCurrent