Thiamine Hydrochloride
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Approved
Approval ID
12986d0e-b8bf-4338-9d85-07f973b35439
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-196
Application NumberANDA091623
Product Classification
M
Marketing Category
C73584
G
Generic Name
thiamine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 24, 2017
FDA Product Classification
INGREDIENTS (4)
MONOTHIOGLYCEROLInactive
Quantity: 5 mg in 1 mL
Code: AAO1P0WSXJ
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Thiamine HydrochlorideActive
Quantity: 100 mg in 1 mL
Code: M572600E5P
Classification: ACTIB