FOSFOMYCIN TROMETHAMINE

Product NDC
70700-268
11-digit product format
707000268
Labeler code
70700
Product ID
70700-268_3b3ab408-446e-20a4-a58c-46bc75451542
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granules for Oral Solution
Dosage form
POWDER
Route
ORAL
Labeler
XIROMED LLC
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-268-94FOSFOMYCIN TROMETHAMINE1 in 1 DOSE PACKPOWDER19
70700-268-94FOSFOMYCIN TROMETHAMINE1 in 1 CARTONPOWDER19
70700-268-99FOSFOMYCIN TROMETHAMINE1 in 1 PACKETPOWDER19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-268FOSFOMYCIN TROMETHAMINE (GRANULES FOR ORAL SOLUTION) POWDER [XIROMED LLC]9Current NDC, Legacy NDC, 3 package rows20230707_c3ba67e7-aaca-e682-277a-94e20b0abad7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSNc3ba67e7-aaca-e682-277a-94e20b0abad79
808917fosfomycin 3000 MG Granules for Oral SolutionSCDc3ba67e7-aaca-e682-277a-94e20b0abad79
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSYc3ba67e7-aaca-e682-277a-94e20b0abad79
808917fosfomycin 3 GM Granules for Oral SolutionSYc3ba67e7-aaca-e682-277a-94e20b0abad79
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
70700-268-94707000268941 DOSE PACK in 1 CARTON (70700-268-94) / 1 POWDER in 1 DOSE PACK1 dose pack2020-10-060000-00-00NoNoCurrent
70700-268-99707000268991 POWDER in 1 PACKET (70700-268-99) 1 powder2020-10-060000-00-00NoNoCurrent