🇺🇸
United States · US · US:76394-2642_2784e7a8-d4f1-fa61-e063-6394a90a614e
Gallium Ga-68 PSMA-11
Orange BookUNIISPLATC V09IX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUCLA Biomedical Cyclotron
CountryUS (United States)
ATC codeV09IX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11763942642312 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)
Annotations
UNII (FDA Substance ID)
ZJ0EKR6M10
GALLIUM GA-68 GOZETOTIDE
RxCUI 2586016
Orange Book
N212642
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ZJ0EKR6M10",
"rxcui": "2586016",
"inchikey": "AEBYHKKMCWUMKX-LNTZDJBBSA-K",
"display_name": "GALLIUM GA-68 GOZETOTIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"357655a4-b3ee-4ea1-a1ea-50d4686546bb": {
"match": "brand_token",
"title": "GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [IONETIX CORPORATION]",
"spl_version": "2",
"published_date": "2026-05-21"
}
},
"productid": "76394-2642_2784e7a8-d4f1-fa61-e063-6394a90a614e",
"productndc": "76394-2642",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "212642",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.5-5mCi/mL",
"product_no": "001",
"approval_date": "Dec 1, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GALLIUM GA-68 GOZETOTIDE",
"proprietary_name": "Gallium Ga-68 PSMA-11",
"active_ingred_unit": "mCi/mL",
"application_number": "NDA212642",
"marketing_category": "NDA",
"nonproprietary_name": "GALLIUM GA-68 GOZETOTIDE",
"start_marketing_date": "20201209",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code V09IX14.
- 🇺🇸Gallium Ga-68 PSMA-11Ionetix Corporation
- 🇺🇸Gallium Ga-68 PSMA-11UCSF Radiopharmaceutical Facility
- DKIlluccixTelix Innovations
- FIIlluccixTelix Innovations
- CAILLUCCIXTELIX PHARMACEUTICALS (US), INC.
- CZILLUCCIXTelix Innovations, Herstal
- CZILLUCCIXTelix Innovations, Herstal
- NLIlluccix 25 microgram kit voor radiofarmaceutisch preparaatTelix Innovations S.A.
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