Vitafol
0642-0093-30 Vitafol Ultra Prenatal Supplement with DHA Rx
Approved
Approval ID
40fa2c3a-f41f-434c-91de-5150a18d3e4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 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.
Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0642-0093
Product Classification
G
Generic Name
Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2023
FDA Product Classification
INGREDIENTS (31)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJ
Classification: IACT
NIACINAMIDEActive
Quantity: 15 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
DOCONEXENTActive
Quantity: 200 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CHOLECALCIFEROLActive
Quantity: 25 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
BETA CAROTENEActive
Quantity: 330 ug in 1 1
Code: 01YAE03M7J
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 1.6 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
ASCORBIC ACIDActive
Quantity: 30 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.8 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
IRONActive
Quantity: 29 mg in 1 1
Code: E1UOL152H7
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIB
POTASSIUM IODIDEActive
Quantity: 150 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIM
CUPRIC OXIDEActive
Quantity: 2 mg in 1 1
Code: V1XJQ704R4
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 20 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
FOLIC ACIDActive
Quantity: 680 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
LEVOMEFOLATE CALCIUMActive
Quantity: 1020 ug in 1 1
Code: A9R10K3F2F
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 9 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM