NEONATAL FE
NEONATAL FE
Approved
Approval ID
d87609be-441e-4b80-97fc-e386ec27d7f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2020
Manufacturers
FDA
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
DUNS: 081225162
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iron, folic acid, cyanocobalamin, ascorbic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73317-8222
Product Classification
G
Generic Name
iron, folic acid, cyanocobalamin, ascorbic acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2020
FDA Product Classification
INGREDIENTS (15)
FOLIC ACIDActive
Quantity: 1000 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 120 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
IRON PENTACARBONYLActive
Quantity: 90 mg in 1 1
Code: 6WQ62TAQ6Z
Classification: ACTIM