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United States · US · US:65857-200_886dbcba-5cf9-4d8b-95c0-d4fc574e8e02

Ammonia

Orange BookUNIISPLATC V09GX05

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

Identification

ManufacturerCardinal Health 414, LLC
CountryUS (United States)
ATC codeV09GX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6585720010
    10 mL in 1 VIAL, GLASS (65857-200-10)

Annotations

UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
A203700
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": "65857-200_886dbcba-5cf9-4d8b-95c0-d4fc574e8e02",
  "productndc": "65857-200",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203700",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30mCi-300mCi/8ML (3.75-37.5mCi/ML)",
        "product_no": "001",
        "approval_date": "Feb 25, 2013"
      }
    ],
    "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": "ANDA203700",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ammonia N-13",
  "start_marketing_date": "20130225",
  "active_numerator_strength": "37.5"
}

Related drugs

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