Nitrofurantoin

Product NDC
63629-7968
11-digit product format
636297968
Labeler code
63629
Product ID
63629-7968_4abb51d7-82df-452d-8306-d3a265f38994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077066
Marketing category
ANDA
Marketing start
2005-04-06
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7968-16362979680114 CAPSULE in 1 BOTTLE (63629-7968-1) 14 capsule2019-03-180000-00-00NoNoCurrent