Fosfomycin Tromethamine

Product NDC
73289-0067
11-digit product format
732890067
Labeler code
73289
Product ID
73289-0067_4f2091cd-2ce0-cc4e-e063-6294a90a3bbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin tromethamine
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Aucta Pharmaceuticals, Inc.
Application
ANDA217772
Marketing category
ANDA
Marketing start
2026-04-09
Substance
FOSFOMYCIN TROMETHAMINE
Active strength
3 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosfomycin Tromethamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSFOMYCIN TROMETHAMINE3 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7FXW6U30GY
Rxcui808917

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
71a697a3-5c0d-49b7-8ae7-06ff4c989d95Product name420250128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73289-0067-1Fosfomycin Tromethamine1 in 1 PACKETGRANULE, FOR SOLUTION11
73289-0067-2Fosfomycin Tromethamine1 in 1 DOSE PACKGRANULE, FOR SOLUTION11
73289-0067-2Fosfomycin Tromethamine1 in 1 CARTONGRANULE, FOR SOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSN4f206750-8126-99a3-e063-6294a90ade4c1
808917fosfomycin 3000 MG Granules for Oral SolutionSCD4f206750-8126-99a3-e063-6294a90ade4c1
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSY4f206750-8126-99a3-e063-6294a90ade4c1
808917fosfomycin 3 GM Granules for Oral SolutionSY4f206750-8126-99a3-e063-6294a90ade4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73289-0067-1732890067011 GRANULE, FOR SOLUTION in 1 PACKET (73289-0067-1) 2026-04-09NoNoHistorical
73289-0067-2732890067021 DOSE PACK in 1 CARTON (73289-0067-2) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK1 dose pack2026-04-09NoNoHistorical