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 ID | 76394-2642_d154f8c5-9446-0a71-e053-2a95a90a7bfa |
| NDC | 76394-2642 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gallium Ga-68 PSMA-11 |
| Generic Name | Gallium Ga-68 Gozetotide |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-12-09 |
| Marketing Category | NDA / |
| Application Number | NDA212642 |
| Labeler Name | UCLA Biomedical Cyclotron |
| Substance Name | GALLIUM GA-68 GOZETOTIDE |
| Active Ingredient Strength | 5 mCi/mL |
| Pharm Classes | Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |