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United States · US · US:13267-456_0bd46b33-99e9-4989-8816-182d7d72babb

Ammonia N 13

Orange BookUNIISPLATC V09GX05

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

Identification

ManufacturerTHE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
CountryUS (United States)
ATC codeV09GX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1326745656
    8 mL in 1 VIAL, GLASS (13267-456-56)

Annotations

UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
N022119
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9OQO0E343Z",
    "rxcui": "1305558",
    "inchikey": "QGZKDVFQNNGYKY-BJUDXGSMSA-N",
    "display_name": "AMMONIA N-13",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "61e196ba-3812-4ffd-8032-12b215378fef": {
      "match": "brand_token",
      "title": "AMMONIA N 13 (AMMONIA N-13) INJECTION [IONETIX CORPORATION]",
      "spl_version": "17",
      "published_date": "2026-03-30"
    }
  },
  "productid": "13267-456_0bd46b33-99e9-4989-8816-182d7d72babb",
  "productndc": "13267-456",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022119",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "30mCi-300mCi/8ML (3.75-37.5mCi/ML)",
        "product_no": "001",
        "approval_date": "Aug 23, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMMONIA N-13",
  "proprietary_name": "Ammonia N 13",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA022119",
  "marketing_category": "NDA",
  "nonproprietary_name": "NH3N13",
  "start_marketing_date": "20070823",
  "active_numerator_strength": "37.5"
}

Related drugs

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