Monoferric
These highlights do not include all the information needed to use MONOFERRIC safely and effectively. See Full Prescribing Information for MONOFERRIC. MONOFERRIC (ferric derisomaltose) injection, for intravenous use Initial U.S. Approval: 2020
Approved
Approval ID
55859d2d-0456-4fa9-b41f-f535accc97db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Pharmacosmos Therapeutics Inc.
DUNS: 117344166
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ferric derisomaltose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73594-9305
Application NumberNDA208171
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ferric derisomaltose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
FERRIC DERISOMALTOSEActive
Quantity: 500 mg in 5 mL
Code: AHU547PI9H
Classification: ACTIM
Ferric derisomaltose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73594-9301
Application NumberNDA208171
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ferric derisomaltose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (5)
NITROGENInactive
Code: N762921K75
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERRIC DERISOMALTOSEActive
Quantity: 100 mg in 1 mL
Code: AHU547PI9H
Classification: ACTIM
Ferric derisomaltose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73594-9310
Application NumberNDA208171
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ferric derisomaltose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
FERRIC DERISOMALTOSEActive
Quantity: 1000 mg in 10 mL
Code: AHU547PI9H
Classification: ACTIM