FDA.reportPublic FDA data

Fosfomycin Tromethamine

Product NDC
82036-4274
Requested package NDC
82036-4274-1
11-digit product format
820364274
Labeler code
82036
Product ID
82036-4274_ea3a4f49-8bac-37c6-e053-2995a90af96b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin Tromethamine
Dosage form
POWDER
Route
ORAL
Labeler
Zambon USA, Ltd
Application
NDA050717
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-08-25
Marketing end
0000-00-00
Substance
FOSFOMYCIN TROMETHAMINE
Active strength
3 g/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82036-427482036-4274-1DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050717-001MONUROLFOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD1996-12-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050717-001MONUROLEQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD1996-12-19a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82036-4274-12025-01-30C16284748780-12cef2736-5dd7-d83d-e063-dadaa90ab31fFosfomycin Tromethamine Granules for Oral Solution Rx only
82036-4274-82025-01-30C16284748780-12cef2736-5dd7-d83d-e063-dadaa90ab31fFosfomycin Tromethamine Granules for Oral Solution Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82036-4274-1EA - Each82036-4274ea8d9d02-f9ba-4f86-bf53-e4f0f9b4ee6112021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82036-4274FOSFOMYCIN TROMETHAMINE POWDER [ZAMBON USA, LTD]6Legacy NDC20231004_ca668546-c8ba-af0a-e053-2995a90a2300.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82036-4274-1820364274011 DOSE PACK in 1 CARTON (82036-4274-1) > 1 POWDER in 1 DOSE PACK1 dose pack2021-08-250000-00-00NoNoCurrent