Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
63629-6777
11-digit product format
636296777
Labeler code
63629
Product ID
63629-6777_fdee7510-f68f-4c06-8262-3b58abae9b4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-6777-16362967770114 CAPSULE in 1 BOTTLE (63629-6777-1) 14 capsule2015-09-080000-00-00NoNoCurrent
63629-6777-26362967770212 CAPSULE in 1 BOTTLE (63629-6777-2) 12 capsule2015-09-080000-00-00NoNoCurrent
63629-6777-36362967770310 CAPSULE in 1 BOTTLE (63629-6777-3) 10 capsule2015-09-080000-00-00NoNoCurrent
63629-6777-46362967770428 CAPSULE in 1 BOTTLE (63629-6777-4) 28 capsule2015-09-080000-00-00NoNoCurrent
63629-6777-56362967770530 CAPSULE in 1 BOTTLE (63629-6777-5) 30 capsule2015-09-080000-00-00NoNoCurrent