NDC Code(s) : 58468-0191-1, 58468-0191-2
Packager : Genzyme Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KynamroMIPOMERSEN SODIUM INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58468-0191
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIPOMERSEN SODIUM(UNII: 18EAY4870E)
(MIPOMERSEN - UNII:9GJ8S4GU0M) 		MIPOMERSEN SODIUM200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58468-0191-11 in 1 CARTON
11 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:58468-0191-24 in 1 CARTON
21 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203568 01/29/2013

PRINCIPAL DISPLAY PANEL

NDC 58468-0191-1

KYNAMRO™
(mipomersen sodium) injection
200 mg/mL

Pre-filled syringe contains 200 mg of mipomersen sodium in 1 mL of solution
For subcutaneous injection only

Rx only

1 Single-use syringe containing 1 mL
Discard unused portion

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton