🇺🇸
United States · US · US:59651-651_f8ec4771-3f8d-473a-a1d0-e42038f61a42
Fosfomycin tromethamine
Orange BookUNIISPLATC J01XX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01XX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651651031 PACKET in 1 CARTON (59651-651-03) / 1 GRANULE, FOR SOLUTION in 1 PACKET
Annotations
UNII (FDA Substance ID)
7FXW6U30GY
FOSFOMYCIN TROMETHAMINE
RxCUI 142135
Orange Book
A217608
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": "59651-651_f8ec4771-3f8d-473a-a1d0-e42038f61a42",
"productndc": "59651-651",
"dosage_form": "GRANULE, FOR SOLUTION",
"orange_book": {
"appl_no": "217608",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 3GM BASE/PACKET",
"product_no": "001",
"approval_date": "Nov 14, 2025"
}
],
"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": "ANDA217608",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosfomycin tromethamine",
"start_marketing_date": "20251114",
"active_numerator_strength": "3"
}Related drugs
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