🇺🇸
United States · US · US:71162-001_4e05ea57-15bf-4f09-e063-6294a90a1c2a
Ammonia N 13
Orange BookUNIISPLATC V09GX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIonetix Corporation
CountryUS (United States)
ATC codeV09GX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171162001055 mL in 1 SYRINGE, PLASTIC (71162-001-05)
Annotations
UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
A210524
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": "71162-001_4e05ea57-15bf-4f09-e063-6294a90a1c2a",
"productndc": "71162-001",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210524",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)",
"product_no": "001",
"approval_date": "Dec 21, 2018"
}
],
"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": "ANDA210524",
"marketing_category": "ANDA",
"nonproprietary_name": "Ammonia N-13",
"start_marketing_date": "20181221",
"active_numerator_strength": "37.5"
}Related drugs
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