Nitrofurantoin Macrocrystals

Product NDC
68071-2517
11-digit product format
680712517
Labeler code
68071
Product ID
68071-2517_ca56360b-c128-b093-e053-2995a90ace1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA073652
Marketing category
ANDA
Marketing start
2007-03-08
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
927AH8112LNITROFURANTOIN67-20-9NITROFURANTOIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2517-26807125170220 CAPSULE in 1 BOTTLE (68071-2517-2) 20 capsule2021-08-240000-00-00NoNoCurrent
68071-2517-6680712517066 CAPSULE in 1 BOTTLE (68071-2517-6) 6 capsule2021-08-240000-00-00NoNoCurrent
68071-2517-76807125170714 CAPSULE in 1 BOTTLE (68071-2517-7) 14 capsule2021-08-240000-00-00NoNoCurrent
68071-2517-86807125170828 CAPSULE in 1 BOTTLE (68071-2517-8) 28 capsule2021-08-240000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx onlyNuCare Pharmaceuticals,Inc.2023-05-19HUMAN PRESCRIPTION DRUG LABEL2