🇺🇸
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
- ndc11763186433030 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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