THAM
THAM SOLUTION Tromethamine Injection
Approved
Approval ID
4af52118-c12b-4ad5-30bb-959848357e8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1593
Application NumberNDA013025
Product Classification
M
Marketing Category
C73594
G
Generic Name
TROMETHAMINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
TROMETHAMINEActive
Quantity: 3.6 g in 100 mL
Code: 023C2WHX2V
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT