This site is intended for healthcare professionals
FDA Hero  Banner - Multi-coloured pills and tablets
  • Home
  • /
  • Drugs
  • /
  • V
  • /
  • Valacyclovir
  • /
  • Valacyclovir VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 Zydus Lifesciences Limited
FDA Drug information

Valacyclovir

Read time: 1 mins
Marketing start date: 14 Jul 2024

Summary of product characteristics


Effective Time

20221105

Version

4

Spl Product Data Elements

Valacyclovir Valacyclovir VALACYCLOVIR HYDROCHLORIDE ACYCLOVIR VALACYCLOVIR CROSPOVIDONE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE CAPSULE 500 Valacyclovir Valacyclovir VALACYCLOVIR HYDROCHLORIDE ACYCLOVIR VALACYCLOVIR CROSPOVIDONE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE CAPSULE 1000

Application Number

ANDA079137

Brand Name

Valacyclovir

Generic Name

Valacyclovir

Product Ndc

65841-630

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-629-06 in bottle of 30 tablets Valacyclovir Tablets USP, 500 mg R x only 30 tablets NDC 65841-630-06 in bottle of 30 tablets Valacyclovir Tablets USP, 1 gram R x only 30 tablets Valacyclovir tablets Valacyclovir tablets

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.