NDC Code(s) : 74725-100-25, 74725-100-64
Packager : Telix Pharmaceuticals (US) Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ILLUCCIXKit for the preparation of gallium Ga 68 gozetotide injection KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:74725-100
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
MANNOSE, D-(UNII: PHA4727WTP)10 ug in 1 1
WATER(UNII: 059QF0KO0R)
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)150 mg in 2.5 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)150 mg in 6.4 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:74725-100-251 in 1 CARTON 17/12/2021
2NDC:74725-100-641 in 1 CARTON 17/12/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214032 12/17/2021

LABELER - Telix Pharmaceuticals (US) Inc.(116991792)

PRINCIPAL DISPLAY PANEL

NDC 74725-100-25
Rx-Only

illuccix ®
(kit for the preparation of gallium
Ga 68 gozetotide Injection)

25 mcg/vial gozetotide

For Intravenous Use Only
Multi-Dose Kit

Kit for the preparation of gallium Ga 68 gozetotide Injection
is supplied as multiple dose kit containing:

  • Prescribing Information
  • Diagnostic label
  • Syringe label
  • Vial 1 (Gozetotide vial) contains 25 mcg gozetotide vial
  • Vial 2A (Acetate Buffer Vial) contains acetate buffer
  • Vial 3 (Sterile Vacuumed Reaction Vial)

Configuration A is for use with
Ga 68 produced via cyclotron
or EZAG GalliaPharm ®

Lot no:

Expiry: YYYY-MM-DD

Important: Store refrigerated upright in original packaging at 2 o to 8 oC (36 o to 46 oF). Do not Freeze. Store radiolabeled gallium Ga 68 gozetotide Injection in radiation shielding at ambient temperature 25 oC (77 oF);

excursions permitted to 15 oC to 30 oC (59 oF to 86 oF), and use within 4 hours.

Warning: Only licensed healthcare professionals who are qualified by specific training in the safe use and handling of radionuclides should use radiopharmaceuticals.

See Prescribing Information for preparation and administration instructions.

Manufactured for:

Telix Pharmaceuticals (US), Inc.

By:

Grand River Aspetic Manufacturing

140 Front Ave SW

Grand Rapids, MI 49504 USA

illuccix-04

PRINCIPAL DISPLAY PANEL

NDC 74725-100-64

Rx Only

illuccix ®

(kit for the preparation of gallium
Ga68 gozetotide Injection)

25 mcg/vial gozetotide

For Intravenous Use Only

Multiple-Dose Kit

​Kit for the preparation of gallium Ga 68 gozetotide Inject is supplied as multiple dose kit
containing:

  • Prescribing Information
  • Diagnostic label
  • Syringe label
  • Vial 1 (Gozetotide vial) contains 25 mcg gozetotide vial
  • Vial 2B (Acetate Buffer Vial) contains acetate buffer
  • Vial 3 (Sterile Vacuumed Reaction Vial)

Configuration B is for use with IRE Galli Eo ®

Lot no:

Expiry: YYYY-MM-DD

Important: Store refrigerated upright in original packaging at 2 o to 8 oC (36 o to 46 oF). Do not Freeze. Store radiolabeled gallium Ga 68 gozetotide Injection in radiation shielding at ambient temperature 25oC (77oF);

excursions permitted to 15 oC to 30 oC (59 oF to 86 oF), and use within 4 hours.

Warning: Only licensed healthcare professionals who are qualified by specific training in the safe use and handling of radionuclides should use radiopharmaceuticals.

See Prescribing Information for preparation and administration instructions.

Manufactured for:

Telix Pharmaceuticals (US), Inc.

By:

Grand River Aspetic Manufacturing

140 Front Ave SW

Grand Rapids, MI 49504 USA

illuccix-05