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United States · US · US:81033-024_3fa646b7-8ad6-3da8-e063-6394a90af80b

Fosfomycin Tromethamine

Orange BookUNIISPLATC J01XX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKesin Pharma Corporation
CountryUS (United States)
ATC codeJ01XX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8103302411
    1 PACKET in 1 CARTON (81033-024-11) / 1 GRANULE, FOR SOLUTION in 1 PACKET (81033-024-03)

Annotations

UNII (FDA Substance ID)
7FXW6U30GY
FOSFOMYCIN TROMETHAMINE
RxCUI 142135
Orange Book
A214554
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": "81033-024_3fa646b7-8ad6-3da8-e063-6394a90af80b",
  "productndc": "81033-024",
  "dosage_form": "GRANULE, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214554",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 3GM BASE/PACKET",
        "product_no": "001",
        "approval_date": "Oct 21, 2021"
      }
    ],
    "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": "ANDA214554",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fosfomycin Tromethamine",
  "start_marketing_date": "20211022",
  "active_numerator_strength": "3"
}

Related drugs

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