fosfomycin tromethamine

Generic: fosfomycin tromethamine

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosfomycin tromethamine
Generic Name fosfomycin tromethamine
Labeler amneal pharmaceuticals ny llc
Dosage Form GRANULE, FOR SOLUTION
Routes
ORAL
Active Ingredients

fosfomycin tromethamine 3 g/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-3955
Product ID 60219-3955_5fd9aeff-694c-48be-93de-a2ba381ea436
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216600
Listing Expiration 2026-12-31
Marketing Start 2024-04-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602193955
Hyphenated Format 60219-3955

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 ANDA216600 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 g/1
source: ndc
Packaging
  • 1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3)
source: ndc

Packages (1)

60219-3955-1 1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3)

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": "5fd9aeff-694c-48be-93de-a2ba381ea436", "openfda": {"unii": ["7FXW6U30GY"], "rxcui": ["808917"], "spl_set_id": ["aacd04a4-f2d5-45a2-b9e7-0e92244a5880"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 PACKET in 1 CARTON (60219-3955-1)  / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3)", "package_ndc": "60219-3955-1", "marketing_start_date": "20240402"}], "brand_name": "Fosfomycin Tromethamine", "product_id": "60219-3955_5fd9aeff-694c-48be-93de-a2ba381ea436", "dosage_form": "GRANULE, FOR SOLUTION", "product_ndc": "60219-3955", "generic_name": "Fosfomycin Tromethamine", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosfomycin Tromethamine", "active_ingredients": [{"name": "FOSFOMYCIN TROMETHAMINE", "strength": "3 g/1"}], "application_number": "ANDA216600", "marketing_category": "ANDA", "marketing_start_date": "20240402", "listing_expiration_date": "20261231"}