FDA.reportPublic FDA data

Monoferric

Product NDC
73594-9301
11-digit product format
735949301
Labeler code
73594
Product ID
73594-9301_ddb3125c-a423-4256-9017-6e614ae2263d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric derisomaltose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacosmos Therapeutics Inc.
Application
NDA208171
Marketing category
NDA
Marketing start
2020-01-16
Substance
FERRIC DERISOMALTOSE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC DERISOMALTOSE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAHU547PI9H
Rxcui2274398, 2274403, 2274406, 2274407, 2274408, 2274409

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73594-9301-2Monoferric5 in 1 BOXINJECTION, SOLUTION513
73594-9301-3Monoferric1 mL in 1 VIALINJECTION, SOLUTION113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73594-9301MONOFERRIC (FERRIC DERISOMALTOSE) INJECTION, SOLUTION [PHARMACOSMOS THERAPEUTICS INC.]12Current NDC, Legacy NDC, 2 package rows20240920_55859d2d-0456-4fa9-b41f-f535accc97db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2274398ferric derisomaltose 100 MG in 1 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274408ferric derisomaltose 1000 MG in 10 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274406ferric derisomaltose 500 MG in 5 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274403MonoFerric 100 MG in 1 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274409MonoFerric 1000 MG in 10 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274407MonoFerric 500 MG in 5 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
22744031 ML ferric derisomaltose 100 MG/ML Injection [Monoferric]SBD55859d2d-0456-4fa9-b41f-f535accc97db13
227440910 ML ferric derisomaltose 100 MG/ML Injection [Monoferric]SBD55859d2d-0456-4fa9-b41f-f535accc97db13
22744075 ML ferric derisomaltose 100 MG/ML Injection [Monoferric]SBD55859d2d-0456-4fa9-b41f-f535accc97db13
22743981 ML ferric derisomaltose 100 MG/ML InjectionSCD55859d2d-0456-4fa9-b41f-f535accc97db13
227440810 ML ferric derisomaltose 100 MG/ML InjectionSCD55859d2d-0456-4fa9-b41f-f535accc97db13
22744065 ML ferric derisomaltose 100 MG/ML InjectionSCD55859d2d-0456-4fa9-b41f-f535accc97db13
22744031 ML Monoferric 100 MG/ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
227440910 ML Monoferric 100 MG/ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
22744075 ML Monoferric 100 MG/ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274398ferric derisomaltose 100 MG per 1 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274408ferric derisomaltose 1000 MG per 10 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274406ferric derisomaltose 500 MG per 5 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274403Monoferric 100 MG per 1 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274409Monoferric 1000 MG per 10 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274407Monoferric 500 MG per 5 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73594-9301-2735949301025 VIAL in 1 BOX (73594-9301-2) / 1 mL in 1 VIAL (73594-9301-3) 5 vial2020-01-160000-00-00NoNoCurrent
73594-9301-3735949301031 mL in 1 VIAL1 mlHistorical