NITROFURANTOIN

Product NDC
72189-179
11-digit product format
721890179
Labeler code
72189
Product ID
72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROFURANTOIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Directrx
Application
ANDA077066
Marketing category
ANDA
Marketing start
2022-01-18
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
927AH8112LNITROFURANTOIN67-20-9NITROFURANTOIN
E1QI2CQQ1INITROFURANTOIN MONOHYDRATE17140-81-7NITROFURANTOIN MONOHYDRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-179-107218901791010 CAPSULE in 1 BOTTLE (72189-179-10) 10 capsule2022-01-18NoNoHistorical
72189-179-147218901791414 CAPSULE in 1 BOTTLE (72189-179-14) 14 capsule2022-01-18NoNoHistorical
72189-179-207218901792020 CAPSULE in 1 BOTTLE (72189-179-20) 20 capsule2022-01-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Directrx2025-01-17HUMAN PRESCRIPTION DRUG LABEL4