valacyclovir

Generic: valacyclovir

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1000 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-263
Product ID 69367-263_e4d63fde-89fa-4570-9939-6f9f2cad56bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209553
Listing Expiration 2026-12-31
Marketing Start 2023-02-14

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 69367263
Hyphenated Format 69367-263

Supplemental Identifiers

RxCUI
313564 313565
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 valacyclovir (source: ndc)
Generic Name valacyclovir (source: ndc)
Application Number ANDA209553 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (69367-263-09)
  • 30 TABLET in 1 BOTTLE (69367-263-30)
source: ndc

Packages (2)

69367-263-09 90 TABLET in 1 BOTTLE (69367-263-09) 69367-263-30 30 TABLET in 1 BOTTLE (69367-263-30)

Ingredients (1)

valacyclovir hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Valacyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e4d63fde-89fa-4570-9939-6f9f2cad56bf", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["4bd97421-1e0a-40a6-a66b-f5f14e827eb3"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (69367-263-09)", "package_ndc": "69367-263-09", "marketing_start_date": "20230214"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (69367-263-30)", "package_ndc": "69367-263-30", "marketing_start_date": "20230214"}], "brand_name": "Valacyclovir", "product_id": "69367-263_e4d63fde-89fa-4570-9939-6f9f2cad56bf", "dosage_form": "TABLET", "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": "69367-263", "generic_name": "Valacyclovir", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA209553", "marketing_category": "ANDA", "marketing_start_date": "20230214", "listing_expiration_date": "20261231"}