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FDA Approval

Zintrexyl-C

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

FDA Approval Summary

Company
PureTek Corporation
DUNS: 785961046
Effective Date
January 11, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin A acetate(1500 ug in 1 1)
Vitamin C(250 mg in 1 1)
Vitamin D3(13.75 ug in 1 1)
Riboflavin(3.35 mg in 1 1)
Thiamine(3.25 mg in 1 1)
Nicotinamide(22.5 mg in 1 1)
Pyridoxine(6 mg in 1 1)
Folic acid(500 ug in 1 1)
Vitamin B12(13 ug in 1 1)
Dexpanthenol(15 mg in 1 1)
Calcium carbonate(75 mg in 1 1)
Zinc oxide(15 mg in 1 1)
Biotin(100 ug in 1 1)
Potassium Iodide(25 ug in 1 1)
Ferrous fumarate(9 mg in 1 1)
Magnesium oxide(37.5 mg in 1 1)
Cupric oxide(1 mg in 1 1)
Manganese sulfate(0.75 mg in 1 1)
Selenious acid(30 ug in 1 1)
Molybdenum(25 ug in 1 1)
Chromium nicotinate(37.5 ug in 1 1)
Potassium chloride(24.5 mg in 1 1)
Boron(25 ug in 1 1)

Products1

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

Zintrexyl-C

Product Details

NDC Product Code
59088-180
Route of Administration
ORAL
Effective Date
January 11, 2023
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACT
ICODEXTRINInactive
Code: 2NX48Z0A9GClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: 3LE3D9D6OYClass: ACTIMQuantity: 1500 ug in 1 1
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 250 mg in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 13.75 ug in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 3.35 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 3.25 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 22.5 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 6 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 500 ug in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 13 ug in 1 1
Code: 19F5HK2737Class: ACTIBQuantity: 15 mg in 1 1
Code: H0G9379FGKClass: ACTIMQuantity: 75 mg in 1 1
Code: SOI2LOH54ZClass: ACTIMQuantity: 15 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 100 ug in 1 1
Code: 1C4QK22F9JClass: ACTIMQuantity: 25 ug in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 9 mg in 1 1
Code: 3A3U0GI71GClass: ACTIMQuantity: 37.5 mg in 1 1
Code: T8BEA5064FClass: ACTIBQuantity: 1 mg in 1 1
Code: W00LYS4T26Class: ACTIMQuantity: 0.75 mg in 1 1
Code: H6241UJ22BClass: ACTIBQuantity: 30 ug in 1 1
Code: 81AH48963UClass: ACTIBQuantity: 25 ug in 1 1
Code: A150AY412VClass: ACTIBQuantity: 37.5 ug in 1 1
Code: 660YQ98I10Class: ACTIMQuantity: 24.5 mg in 1 1
BoronActive
Code: N9E3X5056QClass: ACTIBQuantity: 25 ug in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 45 mg in 1 1
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