valacyclovir hydrochloride

Product NDC

68788-9984

11-digit product format

687889984

Labeler code

68788

Product ID

68788-9984_aceef6fe-fe5f-463e-8d3f-6aa2eb422397

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

valacyclovir hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA201506

Marketing category

ANDA

Marketing start

2015-05-04

Marketing end

0000-00-00

Substance

VALACYCLOVIR HYDROCHLORIDE

Active strength

1 g/1

Pharmacologic classes

DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record