NDC 76394-2642

Gallium Ga-68 PSMA-11

Gallium Ga-68 Gozetotide

Gallium Ga-68 PSMA-11 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ucla Biomedical Cyclotron. The primary component is Gallium Ga-68 Gozetotide.

Product ID76394-2642_d154f8c5-9446-0a71-e053-2a95a90a7bfa
NDC76394-2642
Product TypeHuman Prescription Drug
Proprietary NameGallium Ga-68 PSMA-11
Generic NameGallium Ga-68 Gozetotide
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-12-09
Marketing CategoryNDA /
Application NumberNDA212642
Labeler NameUCLA Biomedical Cyclotron
Substance NameGALLIUM GA-68 GOZETOTIDE
Active Ingredient Strength5 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 76394-2642-3

12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)
Marketing Start Date2020-12-09
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Gallium Ga-68 PSMA-11" or generic name "Gallium Ga-68 Gozetotide"

NDCBrand NameGeneric Name
24275-0525Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDE
76394-2642Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDE

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