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NDC 76394-2642-03 Gallium Ga-68 PSMA-11 5 mCi/mL Details
Gallium Ga-68 PSMA-11 5 mCi/mL
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 Information
| NDC | 76394-2642 |
|---|---|
| Product ID | 76394-2642_eec8a589-3cee-b71c-e053-2995a90a3a5f |
| Associated GPIs | 94356530302020 |
| GCN Sequence Number | 081735 |
| GCN Sequence Number Description | gallium Ga-68 gozetotide VIAL 18.5-185 INTRAVEN |
| HIC3 | Z5B |
| HIC3 Description | RADIOPHARMACEUTICALS ELEMENTS |
| GCN | 48934 |
| HICL Sequence Number | 047013 |
| HICL Sequence Number Description | GALLIUM GA-68 GOZETOTIDE |
| Brand/Generic | Generic |
| Proprietary Name | Gallium Ga-68 PSMA-11 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | GALLIUM GA-68 GOZETOTIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mCi/mL |
| Substance Name | GALLIUM GA-68 GOZETOTIDE |
| Labeler Name | UCLA Biomedical Cyclotron |
| Pharmaceutical Class | Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212642 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76394-2642-03 (76394264203)
| NDC Package Code | 76394-2642-3 |
|---|---|
| Billing NDC | 76394264203 |
| Package | 12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3) |
| Marketing Start Date | 2020-12-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |