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United States · US · US:24450-113_19040c38-c4fb-4162-9f11-b296c1e43736

AMMONIA N-13

Orange BookUNIISPLATC V09GX05

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

Identification

ManufacturerBrigham and Women's Hospital, Inc., The
CountryUS (United States)
ATC codeV09GX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2445011310
    10 mL in 1 VIAL, GLASS (24450-113-10)

Annotations

UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
A203783
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": "24450-113_19040c38-c4fb-4162-9f11-b296c1e43736",
  "productndc": "24450-113",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203783",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30mCi-300mCi/8ML (3.75-37.5mCi/ML)",
        "product_no": "001",
        "approval_date": "Oct 30, 2014"
      }
    ],
    "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": "ANDA203783",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMMONIA N-13",
  "start_marketing_date": "20141101",
  "active_numerator_strength": "37.5"
}

Related drugs

Other records sharing ATC code V09GX05.

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