valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

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

Drug Facts

Product Profile

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

valacyclovir hydrochloride 1 g/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-703
Product ID 51655-703_4950f429-3a5a-cfbc-e063-6294a90a5193
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090682
Listing Expiration 2027-12-31
Marketing Start 2023-04-03

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 51655703
Hyphenated Format 51655-703

Supplemental Identifiers

RxCUI
313564
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 hydrochloride (source: ndc)
Application Number ANDA090682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-04)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-21)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-53)
source: ndc

Packages (3)

51655-703-04 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-04) 51655-703-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-21) 51655-703-53 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-53)

Ingredients (1)

valacyclovir hydrochloride (1 g/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": "4950f429-3a5a-cfbc-e063-6294a90a5193", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313564"], "spl_set_id": ["f98aea50-e4d9-c0cc-e053-6294a90a811c"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-04)", "package_ndc": "51655-703-04", "marketing_start_date": "20230815"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-21)", "package_ndc": "51655-703-21", "marketing_start_date": "20230403"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-703-53)", "package_ndc": "51655-703-53", "marketing_start_date": "20230615"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "51655-703_4950f429-3a5a-cfbc-e063-6294a90a5193", "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": "51655-703", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir Hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA090682", "marketing_category": "ANDA", "marketing_start_date": "20230403", "listing_expiration_date": "20271231"}