🇺🇸
United States · US · US:52768-100_318c2020-f260-4b67-8df3-95ee2cf2b49e
AMMONIA N-13
Orange BookUNIISPLATC V09GX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrecision Nuclear LLC
CountryUS (United States)
ATC codeV09GX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1152768100033 mL in 1 SYRINGE (52768-100-03)
- ndc1152768100055 mL in 1 SYRINGE (52768-100-05)
- ndc11527681003030 mL in 1 VIAL, MULTI-DOSE (52768-100-30)
- ndc11527681005050 mL in 1 VIAL, MULTI-DOSE (52768-100-50)
Annotations
UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
A204547
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": "52768-100_318c2020-f260-4b67-8df3-95ee2cf2b49e",
"productndc": "52768-100",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "204547",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "3.75mCi-260mCi/ML",
"product_no": "001",
"approval_date": "Aug 14, 2015"
}
],
"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": "ANDA204547",
"marketing_category": "ANDA",
"nonproprietary_name": "AMMONIA N-13",
"start_marketing_date": "20101010",
"active_numerator_strength": "260"
}Related drugs
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