FDA.reportPublic FDA data

Monurol

Product NDC
0456-4300
Requested package NDC
0456-4300-01
11-digit product format
004564300
Labeler code
0456
Product ID
0456-4300_427e74c9-6716-451d-8aa1-ef33ebe59dab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin tromethamine
Dosage form
POWDER
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA050717
Marketing category
NDA
Marketing start
1996-12-19
Marketing end
2023-11-30
Substance
FOSFOMYCIN TROMETHAMINE
Active strength
3 g/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage0456-43000456-4300-01DDiscontinued 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TROMETHAMINEEQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD1996-12-19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3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD1996-12-19a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-4300-01EA - Each0456-43008255983e-fef3-4c52-bf7c-7344af3f8a5d12015-03-03
0456-4300-08EA - Each0456-430007935885-a4af-41a2-935a-d49306da7b3112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fosfomycin tromethamineACTIVE INGREDIENT7FXW6U30GYMONUROL (FOSFOMYCIN TROMETHAMINE) POWDER [FOREST LABORATORIES]6
FosfomycinACTIVE MOIETY2N81MY12TEMONUROL (FOSFOMYCIN TROMETHAMINE) POWDER [FOREST LABORATORIES]6
orangeINACTIVE INGREDIENT5EVU04N5QUMONUROL (FOSFOMYCIN TROMETHAMINE) POWDER [FOREST LABORATORIES]6
saccharinINACTIVE INGREDIENTFST467XS7DMONUROL (FOSFOMYCIN TROMETHAMINE) POWDER [FOREST LABORATORIES]6
sucroseINACTIVE INGREDIENTC151H8M554MONUROL (FOSFOMYCIN TROMETHAMINE) POWDER [FOREST LABORATORIES]6
tangerineINACTIVE INGREDIENTKH3E3096OOMONUROL (FOSFOMYCIN TROMETHAMINE) POWDER [FOREST LABORATORIES]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-4300-01004564300011 PACKET in 1 CARTON (0456-4300-01) > 1 POWDER in 1 PACKET (0456-4300-08) 1 packet1996-12-192023-11-30NoNoCurrent