Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
50090-0865
11-digit product format
500900865
Labeler code
50090
Product ID
50090-0865_32bda193-9e6f-436a-b800-6051544b0cd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA020064
Marketing category
NDA
Marketing start
2011-05-25
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0865-0EA - Each50090-0865f8ccc400-7b30-4344-b999-7853a79971bc12018-10-11
50090-0865-1EA - Each50090-0865e2c7e708-4563-48a3-ab19-b50d8daa921812018-10-11
50090-0865-2EA - Each50090-0865e0073cb5-4cda-4085-b705-8c2efc2021d012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0865NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [A-S MEDICATION SOLUTIONS]18Legacy NDC20231210_93ab0f4a-37cb-471b-991f-77d69c84806d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0865-05009008650014 CAPSULE in 1 BOTTLE (50090-0865-0) 14 capsule2014-11-280000-00-00NoNoCurrent
50090-0865-15009008650110 CAPSULE in 1 BOTTLE (50090-0865-1) 10 capsule2014-11-280000-00-00NoNoCurrent
50090-0865-2500900865026 CAPSULE in 1 BOTTLE (50090-0865-2) 6 capsule2016-09-300000-00-00NoNoCurrent