Vitafol
Vitafol -Nano Preconception and Prenatal Supplement
Approved
Approval ID
d4c2b6ae-0a15-435d-bc6c-7443b1306d18
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2023
Manufacturers
FDA
Exeltis USA, Inc.
DUNS: 071170534
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHOLECALCIFEROL, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, and Iodine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0642-0094
Product Classification
G
Generic Name
CHOLECALCIFEROL, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, and Iodine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2023
FDA Product Classification
INGREDIENTS (23)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CHOLECALCIFEROLActive
Quantity: 25 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 680 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
IODINEActive
Quantity: 150 ug in 1 1
Code: 9679TC07X4
Classification: ACTIB
LEVOMEFOLATE CALCIUMActive
Quantity: 1020 ug in 1 1
Code: A9R10K3F2F
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
IRONActive
Quantity: 18 mg in 1 1
Code: E1UOL152H7
Classification: ACTIB