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FDA Approval

Vitamin B Complex

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

FDA Approval Summary

Effective Date
December 31, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dexpanthenol(2 mg in 1 mL)
Nicotinamide(100 mg in 1 mL)
Thiamine(100 mg in 1 mL)
Pyridoxine(2 mg in 1 mL)

Products1

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

Vitamin B Complex

Product Details

NDC Product Code
69877-026
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
December 31, 2015
Code: 20RD1DZH99Class: ACTIMQuantity: 2 mg in 1 mL
Code: 1O6C93RI7ZClass: ACTIBQuantity: 2 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 20 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Code: 25X51I8RD4Class: ACTIBQuantity: 100 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ThiamineActive
Code: M572600E5PClass: ACTIBQuantity: 100 mg in 1 mL
Code: 68Y4CF58BVClass: ACTIBQuantity: 2 mg in 1 mL
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