Metronidazole

Product NDC

57664-653

11-digit product format

576640653

Labeler code

57664

Product ID

57664-653_3130c0b1-b7d5-4d0b-8511-971de4a04687

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Metronidazole

Dosage form

TABLET

Route

ORAL

Labeler

Sun Pharmaceutical Industries, Inc.

Application

ANDA070772

Marketing category

ANDA

Marketing start

1986-07-16

Marketing end

0000-00-00

Substance

METRONIDAZOLE

Active strength

250 mg/1

Pharmacologic classes

Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record