Nitrofurantoin

Product NDC
71335-2255
11-digit product format
713352255
Labeler code
71335
Product ID
71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc
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
71335-2255-17133522550140 CAPSULE in 1 BOTTLE (71335-2255-1) 40 capsule2023-10-02NoNoHistorical
71335-2255-27133522550228 CAPSULE in 1 BOTTLE (71335-2255-2) 28 capsule2023-10-02NoNoHistorical
71335-2255-37133522550330 CAPSULE in 1 BOTTLE (71335-2255-3) 30 capsule2023-10-02NoNoHistorical
71335-2255-47133522550420 CAPSULE in 1 BOTTLE (71335-2255-4) 20 capsule2023-10-02NoNoHistorical
71335-2255-57133522550514 CAPSULE in 1 BOTTLE (71335-2255-5) 14 capsule2023-10-02NoNoHistorical
71335-2255-67133522550610 CAPSULE in 1 BOTTLE (71335-2255-6) 10 capsule2023-10-02NoNoHistorical
71335-2255-77133522550712 CAPSULE in 1 BOTTLE (71335-2255-7) 12 capsule2023-10-02NoNoHistorical
71335-2255-87133522550890 CAPSULE in 1 BOTTLE (71335-2255-8) 90 capsule2023-10-02NoNoHistorical
71335-2255-9713352255096 CAPSULE in 1 BOTTLE (71335-2255-9) 6 capsule2023-10-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)Bryant Ranch Prepack2023-10-02HUMAN PRESCRIPTION DRUG LABEL100