Tranexamic Acid
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1986
Approved
Approval ID
82bc4879-bcf5-47c4-8636-a73c4e7d0de9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code62559-265
Application NumberANDA203256
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 30, 2022
Generic NameTranexamic Acid
INGREDIENTS (8)
TRANEXAMIC ACIDActive
Quantity: 650 mg in 1 1
Code: 6T84R30KC1
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT