Valacyclovir hydrochloride

Product NDC

45963-559

11-digit product format

459630559

Labeler code

45963

Product ID

45963-559_04251821-ac41-4f74-acdc-96fe11febe81

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Valacyclovir hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

ANDA090370

Marketing category

ANDA

Marketing start

2011-04-25

Marketing end

2019-12-31

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

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record