Ga-68-DOTATOC (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 14 mL Vial Label

DOTATOC Ga 68 INJECTION

BATCH#
Diagnostic — For intravenous Use Only
Contains: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of no-carrier
added Ga-68 DOTATOC @ end of synthesis; 9 mg/mL of sodium chloride

Rx ONLY

Sterile, non-pyrogenic

Multiple-dose Vial

NDC# 24417-681-30

Manufactured by:
UIHC-PET Imaging Center
200 Hawkins Drive
Iowa City, IA 52242

TOTAL ACTIVITY: mCi
TOTAL VOLUME: mL
RADIOACTIVE CONCENTRATION: mCi/mL @ EOS TIME
EOS TIME:
EXPIRATION TIME:

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F–86°F);
Store upright in a lead shielded container. Expires 3 hours from end of synthesis.
See full prescribing information for dosage and administration information.

Do not use if cloudy or if contains particulate matter.CAUTION: RADIOACTIVE MATERIAL

PRINCIPAL DISPLAY PANEL -- 14 mL Vial Label
(click image for full-size original)
GA-68-DOTATOC edotreotide gallium ga-68 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24417-681
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EDOTREOTIDE GALLIUM GA-68 (EDOTREOTIDE GALLIUM GA-68) EDOTREOTIDE GALLIUM GA-68 4 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
sodium chloride
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24417-681-30 14 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210828 09/01/2019
Labeler — UIHC – P E T Imaging Center (063513265)

Revised: 09/2019 UIHC – P E T Imaging Center

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