Nitrofurantoin

Product NDC
72789-387
11-digit product format
727890387
Labeler code
72789
Product ID
72789-387_4122c8e9-5b3e-ef7a-e063-6394a90ad345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
72789-387-107278903871010 CAPSULE in 1 BOTTLE, PLASTIC (72789-387-10) 10 capsule2024-03-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)PD-Rx Pharmaceuticals, Inc.2025-10-14HUMAN PRESCRIPTION DRUG LABEL8
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)PD-Rx Pharmaceuticals, Inc.2024-03-12HUMAN PRESCRIPTION DRUG LABEL7