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FDA Approval

Vitafol Fe Plus

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Exeltis USA, Inc.
DUNS: 071170534
Effective Date
February 14, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
levomefolate calcium(1020 ug in 1 1)
Folic acid(680 mg in 1 1)
Doconexent(200 mg in 1 1)
Nicotinamide(15 mg in 1 1)
Vitamin D3(25 mg in 1 1)
Beta carotene(330 ug in 1 1)
Vitamin C(60 mg in 1 1)
Thiamine(1.6 mg in 1 1)
Riboflavin(1.8 mg in 1 1)
Pyridoxine(2.5 mg in 1 1)
Vitamin B12(25 ug in 1 1)
Iron(90 mg in 1 1)
Zinc oxide(25 mg in 1 1)
Cupric oxide(2 mg in 1 1)
Potassium Iodide(150 ug in 1 1)
Magnesium oxide(20 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Vitafol Fe Plus

Product Details

NDC Product Code
0642-7473
Route of Administration
ORAL
Effective Date
February 14, 2023
Code: A9R10K3F2FClass: ACTIBQuantity: 1020 ug in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 680 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2VClass: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YIClass: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8Class: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0NClass: IACT
CORN OILInactive
Code: 8470G57WFMClass: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01Class: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
Code: ZAD9OKH9JCClass: ACTIBQuantity: 200 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 15 mg in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 25 mg in 1 1
Code: 01YAE03M7JClass: ACTIBQuantity: 330 ug in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.6 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.8 mg in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 2.5 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 25 ug in 1 1
IronActive
Code: E1UOL152H7Class: ACTIBQuantity: 90 mg in 1 1
Code: SOI2LOH54ZClass: ACTIBQuantity: 25 mg in 1 1
Code: V1XJQ704R4Class: ACTIMQuantity: 2 mg in 1 1
Code: 1C4QK22F9JClass: ACTIBQuantity: 150 ug in 1 1
Code: 3A3U0GI71GClass: ACTIBQuantity: 20 mg in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 9 mg in 1 1
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