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United States · US · US:68094-064_f59f5f6f-5038-436d-8ed4-fb1dfce51c1e
Fosfomycin Tromethamine
Orange BookUNIISPLATC J01XX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrecision Dose, Inc.
CountryUS (United States)
ATC codeJ01XX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168094064201 PACKET in 1 CARTON (68094-064-20) / 1 GRANULE in 1 PACKET (68094-064-01)
Annotations
UNII (FDA Substance ID)
7FXW6U30GY
FOSFOMYCIN TROMETHAMINE
RxCUI 142135
Orange Book
A217187
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": "68094-064_f59f5f6f-5038-436d-8ed4-fb1dfce51c1e",
"productndc": "68094-064",
"dosage_form": "GRANULE",
"orange_book": {
"appl_no": "217187",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 3GM BASE/PACKET",
"product_no": "001",
"approval_date": "Jun 3, 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": "ANDA217187",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosfomycin Tromethamine",
"start_marketing_date": "20260215",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code J01XX.
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