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United States · US · US:70700-268_3b3ab408-446e-20a4-a58c-46bc75451542
FOSFOMYCIN TROMETHAMINE
Orange BookUNIISPLATC J01XX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXIROMED LLC
CountryUS (United States)
ATC codeJ01XX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170700268941 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACK
- ndc1170700268991 POWDER in 1 PACKET (70700-268-99)
Annotations
UNII (FDA Substance ID)
7FXW6U30GY
FOSFOMYCIN TROMETHAMINE
RxCUI 142135
Orange Book
A212548
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": "70700-268_3b3ab408-446e-20a4-a58c-46bc75451542",
"productndc": "70700-268",
"dosage_form": "POWDER",
"orange_book": {
"appl_no": "212548",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "EQ 3GM BASE/PACKET",
"product_no": "001",
"approval_date": "Oct 6, 2020"
}
],
"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": "ANDA212548",
"marketing_category": "ANDA",
"nonproprietary_name": "Granules for Oral Solution",
"start_marketing_date": "20201006",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code J01XX.
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