Nitrofurantoin

Product NDC
0591-3685
11-digit product format
005913685
Labeler code
0591
Product ID
0591-3685_203cbe0b-de02-402f-8aeb-1adb0b816866
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA091095
Marketing category
ANDA
Marketing start
2015-10-01
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
50 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], 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
0591-3685-01EA - Each0591-3685e561e453-c6e3-4af7-ade2-5d4630ded71c12015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3685-0100591368501100 CAPSULE in 1 BOTTLE (0591-3685-01) 100 capsule2015-10-010000-00-00NoNoCurrent
0591-3685-0500591368505500 CAPSULE in 1 BOTTLE (0591-3685-05) 500 capsule2015-10-010000-00-00NoNoCurrent
0591-3685-10005913685101000 CAPSULE in 1 BOTTLE (0591-3685-10) 1000 capsule2015-10-010000-00-00NoNoCurrent
0591-3685-300059136853030 CAPSULE in 1 BOTTLE (0591-3685-30) 30 capsule2015-10-010000-00-00NoNoCurrent