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FDA Approval

Thiamine Hydrochloride

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

FDA Approval Summary

Company
Effective Date
April 15, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Thiamine(100 mg in 1 mL)

Products1

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

Thiamine Hydrochloride

Product Details

NDC Product Code
67457-196
Application Number
ANDA091623
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
January 24, 2017
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJClass: IACTQuantity: 5 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
ThiamineActive
Code: M572600E5PClass: ACTIBQuantity: 100 mg in 1 mL
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