fosfomycin tromethamine

Generic: granules for oral solution

Labeler: xiromed llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosfomycin tromethamine
Generic Name granules for oral solution
Labeler xiromed llc
Dosage Form POWDER
Routes
ORAL
Active Ingredients

fosfomycin tromethamine 3 g/1

Manufacturer
XIROMED LLC

Identifiers & Regulatory

Product NDC 70700-268
Product ID 70700-268_3b3ab408-446e-20a4-a58c-46bc75451542
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212548
Listing Expiration 2026-12-31
Marketing Start 2020-10-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700268
Hyphenated Format 70700-268

Supplemental Identifiers

RxCUI
808917
UPC
0370700268940
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 granules for oral solution (source: ndc)
Application Number ANDA212548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 g/1
source: ndc
Packaging
  • 1 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACK
  • 1 POWDER in 1 PACKET (70700-268-99)
source: ndc

Packages (2)

70700-268-94 1 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACK 70700-268-99 1 POWDER in 1 PACKET (70700-268-99)

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": "3b3ab408-446e-20a4-a58c-46bc75451542", "openfda": {"upc": ["0370700268940"], "unii": ["7FXW6U30GY"], "rxcui": ["808917"], "spl_set_id": ["c3ba67e7-aaca-e682-277a-94e20b0abad7"], "manufacturer_name": ["XIROMED LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 DOSE PACK in 1 CARTON (70700-268-94)  / 1 POWDER in 1 DOSE PACK", "package_ndc": "70700-268-94", "marketing_start_date": "20201006"}, {"sample": false, "description": "1 POWDER in 1 PACKET (70700-268-99)", "package_ndc": "70700-268-99", "marketing_start_date": "20201006"}], "brand_name": "FOSFOMYCIN TROMETHAMINE", "product_id": "70700-268_3b3ab408-446e-20a4-a58c-46bc75451542", "dosage_form": "POWDER", "product_ndc": "70700-268", "generic_name": "Granules for Oral Solution", "labeler_name": "XIROMED LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FOSFOMYCIN TROMETHAMINE", "active_ingredients": [{"name": "FOSFOMYCIN TROMETHAMINE", "strength": "3 g/1"}], "application_number": "ANDA212548", "marketing_category": "ANDA", "marketing_start_date": "20201006", "listing_expiration_date": "20261231"}