Monurol

Product NDC
0456-4300
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

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

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
0456-4300-08004564300081 POWDER in 1 PACKET (0456-4300-08) 1 powder1996-12-190000-00-00NoNoCurrent