Tranexamic Acid
These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986
Approved
Approval ID
cbc6f5b3-927e-4a94-8836-dbcd47ef97a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tranexamic Acid
PRODUCT DETAILS
NDC Product Code60687-750
Application NumberANDA203256
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 1, 2023
Generic NameTranexamic Acid
INGREDIENTS (8)
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRANEXAMIC ACIDActive
Quantity: 650 mg in 1 1
Code: 6T84R30KC1
Classification: ACTIB