valacyclovir hydrochloride

Product NDC

70518-2928

11-digit product format

705182928

Labeler code

70518

Product ID

70518-2928_dd15ed4a-d3d3-2bf7-e053-2a95a90a6062

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

valacyclovir hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA201506

Marketing category

ANDA

Marketing start

2020-10-30

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

No

Listing certified through

2023-12-31

Current FDA listing

Historical FDA.report record