Thiamine
Approved
Approval ID
8909424c-9d5b-4e35-b2d3-da9d3316a4cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Thiamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-129
Application NumberANDA215692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (4)
CHLOROBUTANOL HEMIHYDRATEInactive
Code: 3X4P6271OX
Classification: IACT
THIAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: M572600E5P
Classification: ACTIB
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJ
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT