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United States · US · US:76318-643_483561c7-747d-40a7-8ed7-134eac3da69c

Ammonia N 13

Orange BookUNIISPLATC V09GX05

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

Identification

ManufacturerMassachusetts General Hospital
CountryUS (United States)
ATC codeV09GX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7631864330
    30 mL in 1 VIAL (76318-643-30)

Annotations

UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
A207025
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": "76318-643_483561c7-747d-40a7-8ed7-134eac3da69c",
  "productndc": "76318-643",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207025",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30mCi-300mCi/8ML (3.75-37.5mCi/ML)",
        "product_no": "001",
        "approval_date": "Feb 3, 2016"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA207025",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ammonia n-13",
  "start_marketing_date": "20160203",
  "active_numerator_strength": "37.5"
}

Related drugs

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