NDC 24417-681

Ga-68-DOTATOC

Edotreotide Gallium Ga-68

Ga-68-DOTATOC is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Uihc . The primary component is Edotreotide Gallium Ga-68.

Product ID24417-681_7e9964bf-ebdc-44c4-a07d-70c6c4e709c1
NDC24417-681
Product TypeHuman Prescription Drug
Proprietary NameGa-68-DOTATOC
Generic NameEdotreotide Gallium Ga-68
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-09-01
Marketing CategoryNDA / NDA
Application NumberNDA210828
Labeler NameUIHC
Substance NameEDOTREOTIDE GALLIUM GA-68
Active Ingredient Strength4 mCi/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24417-681-30

14 mL in 1 VIAL, MULTI-DOSE (24417-681-30)
Marketing Start Date2019-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24417-681-30 [24417068130]

Ga-68-DOTATOC INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA210828
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-01

Drug Details

Active Ingredients

IngredientStrength
EDOTREOTIDE GALLIUM GA-684 mCi/mL

OpenFDA Data

SPL SET ID:c4d185c3-d520-462d-ba50-4f4ee485ace3
Manufacturer
UNII

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.