Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Avion Pharmaceuticals, LLC
965450542
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Avion Pharmaceuticals, LLC
Avion Pharmaceuticals, LLC
Avion Pharmaceuticals, LLC
040348516
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Niferex
Product Details
NDC Product Code
75854-344Route of Administration
ORALEffective Date
April 8, 2025CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Code: H7426RGB3LClass: ACTIMQuantity: 75 mg in 1 1
Succinic acidActive
Code: AB6MNQ6J6LClass: ACTIBQuantity: 150 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 175 mg in 1 1
Folic acidActive
Code: 935E97BOY8Class: ACTIBQuantity: 250 ug in 1 1
Vitamin B12Active
Code: P6YC3EG204Class: ACTIBQuantity: 25 ug in 1 1
ZincActive
Code: J41CSQ7QDSClass: ACTIBQuantity: 15 mg in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYDROXYPROPYL METHYLCELLULOSEInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
levomefolate calciumActive
Code: Q65PL71Q1AClass: ACTIBQuantity: 750 ug in 1 1