Ammonia N 13

Orange BookUNIISPLATC V09GX05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerWashington University School of Medicine

CountryUS (United States)

ATC codeV09GX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7591311310
10 mL in 1 VIAL, GLASS (75913-113-10)

Annotations

UNII (FDA Substance ID)

9OQO0E343Z

AMMONIA N-13

RxCUI 1305558

Orange Book

A204506

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": "75913-113_cf85b16b-e523-0fd2-e053-2a95a90a129d",
  "productndc": "75913-113",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204506",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30mCi-300mCi/8ML (3.75-37.5mCi/ML)",
        "product_no": "001",
        "approval_date": "Feb 7, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "37.5mCi-800mCi/10ML (3.75-80mCi/ML)",
        "product_no": "002",
        "approval_date": "Feb 13, 2026"
      }
    ],
    "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": "ANDA204506",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NH3N13",
  "start_marketing_date": "20120320",
  "active_numerator_strength": "37.5"
}

Related drugs

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