gallium ga-68 psma-11

Generic: gallium ga-68 gozetotide

Labeler: ucla biomedical cyclotron
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gallium ga-68 psma-11
Generic Name gallium ga-68 gozetotide
Labeler ucla biomedical cyclotron
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gallium ga-68 gozetotide 5 mCi/mL

Manufacturer
UCLA Biomedical Cyclotron

Identifiers & Regulatory

Product NDC 76394-2642
Product ID 76394-2642_2784e7a8-d4f1-fa61-e063-6394a90a614e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212642
Listing Expiration 2026-12-31
Marketing Start 2020-12-09

Pharmacologic Class

Established (EPC)
radioactive diagnostic agent [epc]
Mechanism of Action
positron emitting activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763942642
Hyphenated Format 76394-2642

Supplemental Identifiers

UNII
ZJ0EKR6M10
NUI
N0000177914 N0000175869

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gallium ga-68 psma-11 (source: ndc)
Generic Name gallium ga-68 gozetotide (source: ndc)
Application Number NDA212642 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mCi/mL
source: ndc
Packaging
  • 12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)
source: ndc

Packages (1)

76394-2642-3 12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)

Ingredients (1)

gallium ga-68 gozetotide (5 mCi/mL)

Linked Drug Pages (1)

Gallium Ga-68 PSMA-11 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2784e7a8-d4f1-fa61-e063-6394a90a614e", "openfda": {"nui": ["N0000177914", "N0000175869"], "unii": ["ZJ0EKR6M10"], "spl_set_id": ["7744bafb-755e-29a2-e053-2991aa0a86a9"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Positron Emitting Activity [MoA]"], "manufacturer_name": ["UCLA Biomedical Cyclotron"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)", "package_ndc": "76394-2642-3", "marketing_start_date": "20201209"}], "brand_name": "Gallium Ga-68 PSMA-11", "product_id": "76394-2642_2784e7a8-d4f1-fa61-e063-6394a90a614e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Positron Emitting Activity [MoA]", "Radioactive Diagnostic Agent [EPC]"], "product_ndc": "76394-2642", "generic_name": "GALLIUM GA-68 GOZETOTIDE", "labeler_name": "UCLA Biomedical Cyclotron", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gallium Ga-68 PSMA-11", "active_ingredients": [{"name": "GALLIUM GA-68 GOZETOTIDE", "strength": "5 mCi/mL"}], "application_number": "NDA212642", "marketing_category": "NDA", "marketing_start_date": "20201209", "listing_expiration_date": "20261231"}