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United States · US · US:60219-3955_5fd9aeff-694c-48be-93de-a2ba381ea436
Fosfomycin Tromethamine
Orange BookUNIISPLATC J01XX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeJ01XX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160219395511 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3)
Annotations
UNII (FDA Substance ID)
7FXW6U30GY
FOSFOMYCIN TROMETHAMINE
RxCUI 142135
Orange Book
A216600
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": "60219-3955_5fd9aeff-694c-48be-93de-a2ba381ea436",
"productndc": "60219-3955",
"dosage_form": "GRANULE, FOR SOLUTION",
"orange_book": {
"appl_no": "216600",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 3GM BASE/PACKET",
"product_no": "001",
"approval_date": "Mar 25, 2024"
}
],
"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": "ANDA216600",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosfomycin Tromethamine",
"start_marketing_date": "20240402",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code J01XX.
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