Nitrofurantoin

Product NDC
42291-574
11-digit product format
422910574
Labeler code
42291
Product ID
42291-574_d57dad64-9e36-4cfe-e053-2995a90a33f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin monohydrate/macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA207372
Marketing category
ANDA
Marketing start
2017-10-31
Marketing end
0000-00-00
Substance
NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength
75 mg/1; mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
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
42291-574-01EA - Each42291-574147c75d4-cde2-4cc1-9d1f-3c2b5072f30912018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-574-0142291057401100 CAPSULE in 1 BOTTLE (42291-574-01) 100 capsule2017-10-310000-00-00NoNoCurrent