NDC Code(s) : 71612-120-02, 71612-150-02, 71612-190-02, 71612-075-02
Packager : NorthStar Medical Radioisotopes, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RadioGenix SystemTechnetium Tc 99m Generator INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71612-120
Route of Administration INTRAVENOUS, INTRAVESICAL, OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M SODIUM PERTECHNETATE(UNII: A0730CX801)
(TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1) 		TECHNETIUM TC-99M PERTECHNETATE12 Ci in 12 Ci
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71612-120-0212 Ci in 1 VIAL, PLASTIC Type 0: Not a Combination Product01/11/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202158 01/11/2021
RadioGenix SystemTechnetium Tc 99m Generator INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71612-150
Route of Administration INTRAVENOUS, INTRAVESICAL, OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M SODIUM PERTECHNETATE(UNII: A0730CX801)
(TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1) 		TECHNETIUM TC-99M PERTECHNETATE15 Ci in 15 Ci
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71612-150-0215 Ci in 1 VIAL, PLASTIC Type 0: Not a Combination Product01/11/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202158 01/11/2021
RadioGenix SystemTechnetium Tc 99m Generator INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71612-190
Route of Administration INTRAVENOUS, INTRAVESICAL, OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M SODIUM PERTECHNETATE(UNII: A0730CX801)
(TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1) 		TECHNETIUM TC-99M PERTECHNETATE19 Ci in 19 Ci
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71612-190-0219 Ci in 1 VIAL, PLASTIC Type 0: Not a Combination Product01/11/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202158 01/11/2021
RadioGenix SystemTechnetium Tc 99m Generator INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71612-075
Route of Administration INTRAVENOUS, INTRAVESICAL, OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M SODIUM PERTECHNETATE(UNII: A0730CX801)
(TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1) 		TECHNETIUM TC-99M PERTECHNETATE7.5 Ci in 7.5 Ci
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71612-075-027.5 Ci in 1 VIAL, PLASTIC Type 0: Not a Combination Product01/11/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202158 01/11/2021

LABELER - NorthStar Medical Radioisotopes, LLC(025677872)

Establishment
Name Address ID/FEI Business Operations
NorthStar Medical Radioisotopes, LLC 080328423 api manufacture(71612-075, 71612-120, 71612-150, 71612-190), pack(71612-075, 71612-120, 71612-150, 71612-190), label(71612-075, 71612-120, 71612-150, 71612-190)

PRINCIPAL DISPLAY PANEL

7.5ci7.5ci7.5ci7.5ci