Fosfomycin Tromethamine

Product NDC
50090-6130
11-digit product format
500906130
Labeler code
50090
Product ID
50090-6130_87e8ae53-7a25-46af-991c-eae474b6aeae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin Tromethamine
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6130-0Fosfomycin Tromethamine1 in 1 CARTONGRANULE, FOR SOLUTION15
50090-6130-0Fosfomycin Tromethamine1 in 1 PACKETGRANULE, FOR SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6130-0EA - Each50090-6130ad12c53d-76a2-43c5-b713-5bc1393515a412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6130FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231102_6b9167a9-80e9-44e1-a609-c3eb78960acf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSN6b9167a9-80e9-44e1-a609-c3eb78960acf5
808917fosfomycin 3000 MG Granules for Oral SolutionSCD6b9167a9-80e9-44e1-a609-c3eb78960acf5
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSY6b9167a9-80e9-44e1-a609-c3eb78960acf5
808917fosfomycin 3 GM Granules for Oral SolutionSY6b9167a9-80e9-44e1-a609-c3eb78960acf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6130-0500906130001 PACKET in 1 CARTON (50090-6130-0) / 1 GRANULE, FOR SOLUTION in 1 PACKET1 packet2022-10-030000-00-00NoNoCurrent