nitrofurantoin

Product NDC
50090-7217
11-digit product format
500907217
Labeler code
50090
Product ID
50090-7217_bb60450d-7bb5-434e-b1d5-23d653a1c2fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-12-01
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], 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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7217-05009072170028 CAPSULE in 1 BOTTLE (50090-7217-0) 28 capsule2024-08-12NoNoHistorical
50090-7217-25009072170220 CAPSULE in 1 BOTTLE (50090-7217-2) 20 capsule2024-08-12NoNoHistorical
50090-7217-35009072170314 CAPSULE in 1 BOTTLE (50090-7217-3) 14 capsule2024-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nitrofurantoin Capsules, USP (Macrocrystals) Rx onlyA-S Medication Solutions2024-08-15HUMAN PRESCRIPTION DRUG LABEL1