Vitafol OB
Vitafol -OB Prenatal Supplement
Approved
Approval ID
22828f24-600d-4aa6-9b3a-cf8c991f9a97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2022
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.
Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, and Copper
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0642-0079
Product Classification
G
Generic Name
Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, and Copper
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2022
FDA Product Classification
INGREDIENTS (42)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TRICALCIUM PHOSPHATEInactive
Code: K4C08XP666
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
VITAMIN AActive
Quantity: 2700 [iU] in 1 1
Code: 81G40H8B0T
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 1.6 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
VITAMIN DActive
Quantity: 400 [iU] in 1 1
Code: 9VU1KI44GP
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.8 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINActive
Quantity: 18 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CALCIUMActive
Quantity: 100 mg in 1 1
Code: SY7Q814VUP
Classification: ACTIB
IRONActive
Quantity: 65 mg in 1 1
Code: E1UOL152H7
Classification: ACTIB
MAGNESIUMActive
Quantity: 25 mg in 1 1
Code: I38ZP9992A
Classification: ACTIB
ZINCActive
Quantity: 25 mg in 1 1
Code: J41CSQ7QDS
Classification: ACTIB
COPPERActive
Quantity: 2 mg in 1 1
Code: 789U1901C5
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ASCORBIC ACIDActive
Quantity: 70 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
.ALPHA.-TOCOPHEROLActive
Quantity: 30 [iU] in 1 1
Code: H4N855PNZ1
Classification: ACTIB