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United States · US · US:69097-579_80c866f4-c984-469e-b2a5-5c23f29b9750

FOSFOMYCIN TROMETHAMINE

Orange BookUNIISPLATC J01XX

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeJ01XX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6909757967
    1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK

Annotations

UNII (FDA Substance ID)
7FXW6U30GY
FOSFOMYCIN TROMETHAMINE
RxCUI 142135
Orange Book
A211881
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": "69097-579_80c866f4-c984-469e-b2a5-5c23f29b9750",
  "productndc": "69097-579",
  "dosage_form": "GRANULE, FOR SOLUTION",
  "orange_book": {
    "appl_no": "211881",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 3GM BASE/PACKET",
        "product_no": "001",
        "approval_date": "Jan 26, 2022"
      }
    ],
    "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": "ANDA211881",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FOSFOMYCIN TROMETHAMINE",
  "start_marketing_date": "20220126",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code J01XX.

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