Tranexamic Acid
These highlights do not include all the information needed to use TRANEXAMIC ACID USP TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID USP TABLETS. TRANEXAMIC ACID, USP tablets, for oral useInitial U.S. Approval: 1986
Approved
Approval ID
031bf7c2-3b07-469d-bc5a-31fc6238e25f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2022
Manufacturers
FDA
Amring Pharmaceuticals, Inc.
DUNS: 079843051
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69918-301
Application NumberNDA022430
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tranexamic Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (8)
Tranexamic AcidActive
Quantity: 650 mg in 1 1
Code: 6T84R30KC1
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT