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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

  • ndc11
    7070026894
    1 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACK
  • ndc11
    7070026899
    1 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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