Nitrofurantoin

Product NDC
50090-6769
11-digit product format
500906769
Labeler code
50090
Product ID
50090-6769_fc77d2b6-7267-4a70-a482-aabcb4673d2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077066
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
2027-03-18
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
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (Twice-a-day Dosage)A-S Medication Solutions2025-08-13HUMAN PRESCRIPTION DRUG LABEL3