Quadramet (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Quadramet
Sterile, Non-pyrogenic, Intravenous Injection
Caution: Radioactive Material

Quadramet Sterile, Non-pyrogenic, Intravenous Injection Caution: Radioactive Material
(click image for full-size original)

QUADRAMET
samarium sm 153 lexidronam injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57902-860
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM (SAMARIUM SM-153) SAMARIUM SM-153 50 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
LEXIDRONAM 35 mg in 1 mL
CALCIUM HYDROXIDE 5.3 mg in 1 mL
SODIUM HYDROXIDE 14 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57902-860-03 3 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020570 05/19/1997
Labeler — Jazz Pharmaceuticals, Inc. (135926363)

Revised: 01/2013 Jazz Pharmaceuticals, Inc.

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