FOSFOMYCIN TROMETHAMINE

Product NDC
50090-5826
11-digit product format
500905826
Labeler code
50090
Product ID
50090-5826_82bcf84a-7f49-423c-a1ec-17befb33993d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granules for Oral
Dosage form
POWDER
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212548
Marketing category
ANDA
Marketing start
2020-10-06
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5826-0FOSFOMYCIN TROMETHAMINE1 in 1 DOSE PACKPOWDER15
50090-5826-0FOSFOMYCIN TROMETHAMINE1 in 1 CARTONPOWDER15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5826-0EA - Each50090-5826530a3d22-bd74-4257-9883-243b34ff4f5c12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5826FOSFOMYCIN TROMETHAMINE (GRANULES FOR ORAL) POWDER [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231125_99becde1-fca5-4d82-8c3e-36ded62fc0d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSN99becde1-fca5-4d82-8c3e-36ded62fc0d15
808917fosfomycin 3000 MG Granules for Oral SolutionSCD99becde1-fca5-4d82-8c3e-36ded62fc0d15
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSY99becde1-fca5-4d82-8c3e-36ded62fc0d15
808917fosfomycin 3 GM Granules for Oral SolutionSY99becde1-fca5-4d82-8c3e-36ded62fc0d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5826-0500905826001 DOSE PACK in 1 CARTON (50090-5826-0) / 1 POWDER in 1 DOSE PACK1 dose pack2021-10-260000-00-00NoNoCurrent