fosfomycin tromethamine

Generic: fosfomycin tromethamine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosfomycin tromethamine
Generic Name fosfomycin tromethamine
Labeler aurobindo pharma limited
Dosage Form GRANULE, FOR SOLUTION
Routes
ORAL
Active Ingredients

fosfomycin tromethamine 3 g/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-651
Product ID 59651-651_f8ec4771-3f8d-473a-a1d0-e42038f61a42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217608
Listing Expiration 2026-12-31
Marketing Start 2025-11-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651651
Hyphenated Format 59651-651

Supplemental Identifiers

RxCUI
808917
UNII
7FXW6U30GY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fosfomycin tromethamine (source: ndc)
Generic Name fosfomycin tromethamine (source: ndc)
Application Number ANDA217608 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 g/1
source: ndc
Packaging
  • 1 PACKET in 1 CARTON (59651-651-03) / 1 GRANULE, FOR SOLUTION in 1 PACKET
source: ndc

Packages (1)

59651-651-03 1 PACKET in 1 CARTON (59651-651-03) / 1 GRANULE, FOR SOLUTION in 1 PACKET

Ingredients (1)

fosfomycin tromethamine (3 g/1)

Linked Drug Pages (1)

Fosfomycin tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f8ec4771-3f8d-473a-a1d0-e42038f61a42", "openfda": {"unii": ["7FXW6U30GY"], "rxcui": ["808917"], "spl_set_id": ["f8ec4771-3f8d-473a-a1d0-e42038f61a42"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 PACKET in 1 CARTON (59651-651-03)  / 1 GRANULE, FOR SOLUTION in 1 PACKET", "package_ndc": "59651-651-03", "marketing_start_date": "20251114"}], "brand_name": "Fosfomycin tromethamine", "product_id": "59651-651_f8ec4771-3f8d-473a-a1d0-e42038f61a42", "dosage_form": "GRANULE, FOR SOLUTION", "product_ndc": "59651-651", "generic_name": "Fosfomycin tromethamine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosfomycin tromethamine", "active_ingredients": [{"name": "FOSFOMYCIN TROMETHAMINE", "strength": "3 g/1"}], "application_number": "ANDA217608", "marketing_category": "ANDA", "marketing_start_date": "20251114", "listing_expiration_date": "20261231"}