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United States · US · US:70681-001_b2d6953c-71de-467f-ae45-54ce4f7a90db

Ammonia

Orange BookUNIISPLATC V09GX05

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

Identification

ManufacturerThe University of Texas Southwestern Medical Center
CountryUS (United States)
ATC codeV09GX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7068100130
    30 mL in 1 VIAL, GLASS (70681-001-30)

Annotations

UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
A209507
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": "70681-001_b2d6953c-71de-467f-ae45-54ce4f7a90db",
  "productndc": "70681-001",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209507",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30mCi-300mCi/8ML (3.75-37.5mCi/ML)",
        "product_no": "001",
        "approval_date": "Nov 1, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMMONIA N-13",
  "proprietary_name": "Ammonia",
  "active_ingred_unit": "mCi/mL",
  "application_number": "ANDA209507",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMMONIA N-13",
  "start_marketing_date": "20200501",
  "active_numerator_strength": "37.5"
}

Related drugs

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