fosfomycin tromethamine

Generic: fosfomycin tromethamine

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosfomycin tromethamine
Generic Name fosfomycin tromethamine
Labeler cipla usa inc.
Dosage Form GRANULE, FOR SOLUTION
Routes
ORAL
Active Ingredients

fosfomycin tromethamine 3 g/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-579
Product ID 69097-579_80c866f4-c984-469e-b2a5-5c23f29b9750
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211881
Listing Expiration 2026-12-31
Marketing Start 2022-01-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097579
Hyphenated Format 69097-579

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 ANDA211881 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 g/1
source: ndc
Packaging
  • 1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK
source: ndc

Packages (1)

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

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": "80c866f4-c984-469e-b2a5-5c23f29b9750", "openfda": {"unii": ["7FXW6U30GY"], "rxcui": ["808917"], "spl_set_id": ["d101b5d8-bffc-4ee6-b93b-4589fcb8750d"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 DOSE PACK in 1 CARTON (69097-579-67)  / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK", "package_ndc": "69097-579-67", "marketing_start_date": "20220126"}], "brand_name": "FOSFOMYCIN TROMETHAMINE", "product_id": "69097-579_80c866f4-c984-469e-b2a5-5c23f29b9750", "dosage_form": "GRANULE, FOR SOLUTION", "product_ndc": "69097-579", "generic_name": "FOSFOMYCIN TROMETHAMINE", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FOSFOMYCIN TROMETHAMINE", "active_ingredients": [{"name": "FOSFOMYCIN TROMETHAMINE", "strength": "3 g/1"}], "application_number": "ANDA211881", "marketing_category": "ANDA", "marketing_start_date": "20220126", "listing_expiration_date": "20261231"}