NDC 49442-9305

Monoferric

Ferric Derisomaltose

Monoferric is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmacosmos A/s. The primary component is Ferric Derisomaltose.

Product ID49442-9305_93bb10c4-9862-4eda-927f-206ab5c2f7f0
NDC49442-9305
Product TypeHuman Prescription Drug
Proprietary NameMonoferric
Generic NameFerric Derisomaltose
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-16
Marketing CategoryNDA / NDA
Application NumberNDA208171
Labeler NamePharmacosmos A/S
Substance NameFERRIC DERISOMALTOSE
Active Ingredient Strength500 mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 49442-9305-1

1 VIAL in 1 BOX (49442-9305-1) > 5 mL in 1 VIAL
Marketing Start Date2020-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49442-9305-1 [49442930501]

Monoferric SOLUTION
Marketing CategoryNDA
Application NumberNDA208171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

Drug Details

Active Ingredients

IngredientStrength
FERRIC DERISOMALTOSE500 mg/5mL

NDC Crossover Matching brand name "Monoferric" or generic name "Ferric Derisomaltose"

NDCBrand NameGeneric Name
49442-9301MonoferricFerric derisomaltose
49442-9305MonoferricFerric derisomaltose
49442-9310MonoferricFerric derisomaltose
73594-9301MonoferricFerric derisomaltose
73594-9305MonoferricFerric derisomaltose
73594-9310MonoferricFerric derisomaltose

Trademark Results [Monoferric]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MONOFERRIC
MONOFERRIC
87839247 5673033 Live/Registered
Pharmacosmos A/S
2018-03-19
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.