NDC Code(s) : 60429-084-30
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tranexamic AcidTranexamic Acid TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-084(NDC:60505-3638)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANEXAMIC ACID(UNII: 6T84R30KC1)
(TRANEXAMIC ACID - UNII:6T84R30KC1) 		TRANEXAMIC ACID650 1
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code APO;TRA650
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-084-3030 in 1 BOTTLE Type 0: Not a Combination Product20/08/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202286 08/20/2014 03/31/2016

PRINCIPAL DISPLAY PANEL

GSMS, Inc. 60429-084-30

Tranexamic Acid Tablets

650 mg

Rx only

30 Tablets

Label_Graphic-650mg-30s.jpg