THIAMINE HYDROCHLORIDE
Thiamine Hydrochloride Injection, USPRx only
Approved
Approval ID
e2b6bd0c-6e45-4edb-8c2a-df1564e6d367
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code70748-347
Application NumberANDA215692
Product Classification
M
Marketing Category
C73584
G
Generic Name
THIAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (4)
THIAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: M572600E5P
Classification: ACTIR
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJ
Classification: IACT
CHLOROBUTANOL HEMIHYDRATEInactive
Code: 3X4P6271OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT