Nitrofurantoin

Product NDC
71335-2320
11-digit product format
713352320
Labeler code
71335
Product ID
71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208516
Marketing category
ANDA
Marketing start
2018-01-01
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
71335-2320-0713352320006 CAPSULE in 1 BOTTLE (71335-2320-0) 6 capsule2024-01-04NoNoHistorical
71335-2320-17133523200120 CAPSULE in 1 BOTTLE (71335-2320-1) 20 capsule2024-01-04NoNoHistorical
71335-2320-27133523200214 CAPSULE in 1 BOTTLE (71335-2320-2) 14 capsule2024-01-04NoNoHistorical
71335-2320-37133523200330 CAPSULE in 1 BOTTLE (71335-2320-3) 30 capsule2024-01-04NoNoHistorical
71335-2320-47133523200428 CAPSULE in 1 BOTTLE (71335-2320-4) 28 capsule2024-01-04NoNoHistorical
71335-2320-57133523200560 CAPSULE in 1 BOTTLE (71335-2320-5) 60 capsule2024-01-04NoNoHistorical
71335-2320-67133523200610 CAPSULE in 1 BOTTLE (71335-2320-6) 10 capsule2024-01-04NoNoHistorical
71335-2320-77133523200790 CAPSULE in 1 BOTTLE (71335-2320-7) 90 capsule2024-01-04NoNoHistorical
71335-2320-87133523200821 CAPSULE in 1 BOTTLE (71335-2320-8) 21 capsule2024-01-04NoNoHistorical
71335-2320-9713352320098 CAPSULE in 1 BOTTLE (71335-2320-9) 8 capsule2024-01-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)Bryant Ranch Prepack2024-01-04HUMAN PRESCRIPTION DRUG LABEL101