ACCRUFER
These highlights do not include all the information needed to use ACCRUFER safely and effectively. See full prescribing information for ACCRUFER. ACCRUFER (ferric maltol) capsules, for oral use Initial U.S. Approval: 2019
Approved
Approval ID
367ac157-2d25-4f34-99ce-b126e0f03851
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Shield TX (UK) Ltd
DUNS: 211237588
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ferric Maltol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73059-001
Application NumberNDA212320
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ferric Maltol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC MALTOLActive
Quantity: 30 mg in 1 1
Code: MA10QYF1Z0
Classification: ACTIM