nitrofurantoin macrocrystals

Product NDC
71335-2212
11-digit product format
713352212
Labeler code
71335
Product ID
71335-2212_286e68d4-754d-4900-9365-901ecccac6b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-03-21
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
71335-2212-17133522120140 CAPSULE in 1 BOTTLE (71335-2212-1) 40 capsule2023-08-15NoNoHistorical
71335-2212-27133522120228 CAPSULE in 1 BOTTLE (71335-2212-2) 28 capsule2023-08-15NoNoHistorical
71335-2212-37133522120330 CAPSULE in 1 BOTTLE (71335-2212-3) 30 capsule2023-08-15NoNoHistorical
71335-2212-47133522120420 CAPSULE in 1 BOTTLE (71335-2212-4) 20 capsule2023-08-15NoNoHistorical
71335-2212-57133522120514 CAPSULE in 1 BOTTLE (71335-2212-5) 14 capsule2023-08-15NoNoHistorical
71335-2212-67133522120610 CAPSULE in 1 BOTTLE (71335-2212-6) 10 capsule2023-08-15NoNoHistorical
71335-2212-77133522120712 CAPSULE in 1 BOTTLE (71335-2212-7) 12 capsule2023-08-15NoNoHistorical
71335-2212-87133522120890 CAPSULE in 1 BOTTLE (71335-2212-8) 90 capsule2023-08-15NoNoHistorical
71335-2212-9713352212096 CAPSULE in 1 BOTTLE (71335-2212-9) 6 capsule2023-08-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nitrofurantoin Capsules, USP (Macrocrystals) Rx onlyBryant Ranch Prepack2023-08-15HUMAN PRESCRIPTION DRUG LABEL100