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United States · US · US:73289-0067_4f2091cd-2ce0-cc4e-e063-6294a90a3bbb
Fosfomycin Tromethamine
Orange BookUNIISPLATC J01XX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAucta Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01XX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1173289006711 GRANULE, FOR SOLUTION in 1 PACKET (73289-0067-1)
- ndc1173289006721 DOSE PACK in 1 CARTON (73289-0067-2) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK
Annotations
UNII (FDA Substance ID)
7FXW6U30GY
FOSFOMYCIN TROMETHAMINE
RxCUI 142135
Orange Book
A217772
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7FXW6U30GY",
"rxcui": "142135",
"inchikey": "QZJIMDIBFFHQDW-LMLSDSMGSA-N",
"display_name": "FOSFOMYCIN TROMETHAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4f206750-8126-99a3-e063-6294a90ade4c": {
"match": "brand_token",
"title": "FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [AUCTA PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-04-13"
}
},
"productid": "73289-0067_4f2091cd-2ce0-cc4e-e063-6294a90a3bbb",
"productndc": "73289-0067",
"dosage_form": "GRANULE, FOR SOLUTION",
"orange_book": {
"appl_no": "217772",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 3GM BASE/PACKET",
"product_no": "001",
"approval_date": "Apr 9, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSFOMYCIN TROMETHAMINE",
"proprietary_name": "Fosfomycin Tromethamine",
"active_ingred_unit": "g/1",
"application_number": "ANDA217772",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosfomycin tromethamine",
"start_marketing_date": "20260409",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code J01XX.
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