nitrofurantoin (macrocrystals)

Product NDC
50090-7308
11-digit product format
500907308
Labeler code
50090
Product ID
50090-7308_b0e07675-526a-4083-a35e-2a93ad10888b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin (macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077025
Marketing category
ANDA
Marketing start
2023-05-17
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
50090-7308-05009073080028 CAPSULE in 1 BOTTLE (50090-7308-0) 28 capsule2024-10-14NoNoHistorical
50090-7308-25009073080220 CAPSULE in 1 BOTTLE (50090-7308-2) 20 capsule2024-10-14NoNoHistorical
50090-7308-35009073080314 CAPSULE in 1 BOTTLE (50090-7308-3) 14 capsule2024-10-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nitrofurantoin Capsules, USP (Macrocrystals) 100 mg Rx onlyA-S Medication Solutions2024-10-15Human Prescription Drug Label1