valacyclovir hydrochloride

Generic: valacyclovir

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-055
Product ID 82868-055_46dcc5db-2924-de8f-e063-6394a90a101f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078518
Listing Expiration 2026-12-31
Marketing Start 2024-05-30

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 82868055
Hyphenated Format 82868-055

Supplemental Identifiers

RxCUI
313565
UNII
G447S0T1VC

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 valacyclovir hydrochloride (source: ndc)
Generic Name valacyclovir (source: ndc)
Application Number ANDA078518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-055-21)
source: ndc

Packages (1)

82868-055-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-055-21)

Ingredients (1)

valacyclovir hydrochloride (500 mg/1)

Linked Drug Pages (1)

Valacyclovir Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46dcc5db-2924-de8f-e063-6394a90a101f", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["1b53c6bb-0e8c-f49a-e063-6294a90a0f5a"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-055-21)", "package_ndc": "82868-055-21", "marketing_start_date": "20240530"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "82868-055_46dcc5db-2924-de8f-e063-6394a90a101f", "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": "82868-055", "generic_name": "valacyclovir", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir Hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078518", "marketing_category": "ANDA", "marketing_start_date": "20240530", "listing_expiration_date": "20261231"}