Fosfomycin Tromethamine

Product NDC
67877-749
11-digit product format
678770749
Labeler code
67877
Product ID
67877-749_0ebb79a9-df22-4fec-b872-b020b5129b14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin Tromethamine
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
67877-749-57Fosfomycin Tromethamine1 in 1 CARTONGRANULE, FOR SOLUTION15
67877-749-57Fosfomycin Tromethamine1 in 1 PACKETGRANULE, FOR SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-749-57EA - Each67877-7499a42e981-7f4b-4d01-aeef-50d2d952335912021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-749FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [ASCEND LABORATORIES, LLC]4Current NDC, Legacy NDC, 2 package rows20220915_48e352bc-52ea-4778-905a-60ef38a5c18a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSN48e352bc-52ea-4778-905a-60ef38a5c18a5
808917fosfomycin 3 GM Granules for Oral SolutionPSN6b9167a9-80e9-44e1-a609-c3eb78960acf5
808917fosfomycin 3000 MG Granules for Oral SolutionSCD48e352bc-52ea-4778-905a-60ef38a5c18a5
808917fosfomycin 3000 MG Granules for Oral SolutionSCD6b9167a9-80e9-44e1-a609-c3eb78960acf5
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSY48e352bc-52ea-4778-905a-60ef38a5c18a5
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSY6b9167a9-80e9-44e1-a609-c3eb78960acf5
808917fosfomycin 3 GM Granules for Oral SolutionSY48e352bc-52ea-4778-905a-60ef38a5c18a5
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
67877-749-57678770749571 PACKET in 1 CARTON (67877-749-57) / 1 GRANULE, FOR SOLUTION in 1 PACKET1 packet2021-10-220000-00-00NoNoCurrent