PRINCIPAL DISPLAY PANEL
Sterile, Non-pyrogenic, Intravenous Injection
Caution: Radioactive Material
| 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 |
|# ||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.
Revised: 01/2013 Jazz Pharmaceuticals, Inc.
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