valtrex

Generic: valacyclovir hydrochloride

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name valtrex
Generic Name valacyclovir hydrochloride
Labeler glaxosmithkline llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1 g/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0565
Product ID 0173-0565_753fde77-5750-4c98-a167-daa531f3d872
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020487
Listing Expiration 2026-12-31
Marketing Start 2002-08-12

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730565
Hyphenated Format 0173-0565

Supplemental Identifiers

RxCUI
108780 212448 313564 313565
UPC
0301730933089
UNII
G447S0T1VC

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name valtrex (source: ndc)
Generic Name valacyclovir hydrochloride (source: ndc)
Application Number NDA020487 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04)
  • 90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10)
source: ndc

Packages (2)

0173-0565-04 30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04) 0173-0565-10 90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10)

Ingredients (1)

valacyclovir hydrochloride (1 g/1)

Linked Drug Pages (1)

VALTREX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "753fde77-5750-4c98-a167-daa531f3d872", "openfda": {"upc": ["0301730933089"], "unii": ["G447S0T1VC"], "rxcui": ["108780", "212448", "313564", "313565"], "spl_set_id": ["f8e0d8f8-cb73-4206-a484-88f5c4fbd719"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04)", "package_ndc": "0173-0565-04", "marketing_start_date": "20020812"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10)", "package_ndc": "0173-0565-10", "marketing_start_date": "20020812"}], "brand_name": "VALTREX", "product_id": "0173-0565_753fde77-5750-4c98-a167-daa531f3d872", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "0173-0565", "generic_name": "valacyclovir hydrochloride", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALTREX", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "NDA020487", "marketing_category": "NDA", "marketing_start_date": "20020812", "listing_expiration_date": "20261231"}