Fosfomycin Tromethamine

Product NDC
81033-024
11-digit product format
810330024
Labeler code
81033
Product ID
81033-024_3fa646b7-8ad6-3da8-e063-6394a90af80b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin Tromethamine
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA214554
Marketing category
ANDA
Marketing start
2021-10-22
Substance
FOSFOMYCIN TROMETHAMINE
Active strength
3 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosfomycin Tromethamine
Listing expiration
2026-12-31

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
81033-024-03Fosfomycin Tromethamine1 in 1 PACKETGRANULE, FOR SOLUTION11
81033-024-11Fosfomycin Tromethamine1 in 1 CARTONGRANULE, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-024-03EA - Each81033-024c310de13-e37e-47b0-8ad8-f6c86277e69112026-04-20
81033-024-11EA - Each81033-0242c449279-387b-4138-b31f-50df719892a312026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSN3fa61bd4-fc55-0987-e063-6394a90abce21
808917fosfomycin 3000 MG Granules for Oral SolutionSCD3fa61bd4-fc55-0987-e063-6394a90abce21
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSY3fa61bd4-fc55-0987-e063-6394a90abce21
808917fosfomycin 3 GM Granules for Oral SolutionSY3fa61bd4-fc55-0987-e063-6394a90abce21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-024-03810330024031 in 1 PACKETHistorical
81033-024-11810330024111 PACKET in 1 CARTON (81033-024-11) / 1 GRANULE, FOR SOLUTION in 1 PACKET (81033-024-03) 1 packet2025-10-01NoNoHistorical