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United States · US · US:69945-180_3c4363ac-ad4f-f5fc-e063-6294a90a1ec2

GALLIUM CITRATE GA-67

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCurium US LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6994518006
    1 VIAL in 1 CAN (69945-180-06) / 3.3 mL in 1 VIAL
  • ndc11
    6994518012
    1 VIAL in 1 CAN (69945-180-12) / 6.6 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
A04B19O2B0
GALLIUM CHLORIDE GA-67
RxCUI 314639
Orange Book
N018058
BS
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "A04B19O2B0",
    "rxcui": "314639",
    "inchikey": "UPWPDUACHOATKO-MPZFSRPWSA-K",
    "display_name": "GALLIUM CHLORIDE GA-67",
    "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": "69945-180_3c4363ac-ad4f-f5fc-e063-6294a90a1ec2",
  "productndc": "69945-180",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018058",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BS",
        "strength": "2mCi/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GALLIUM CHLORIDE GA-67",
  "proprietary_name": "GALLIUM CITRATE GA-67",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA018058",
  "marketing_category": "NDA",
  "nonproprietary_name": "gallium citrate ga-67",
  "start_marketing_date": "20080221",
  "active_numerator_strength": "2"
}

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