Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC

55700-532

11-digit product format

557000532

Labeler code

55700

Product ID

55700-532_12c687b9-9be1-4374-8c80-67243ebae48a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Nitrofurantoin Monohydrate/Macrocrystalline

Dosage form

CAPSULE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

NDA020064

Marketing category

NDA

Marketing start

2011-05-25

Marketing end

0000-00-00

Substance

NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE

Active strength

25 mg/1; mg/1

Pharmacologic classes

Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record