valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-053
Product ID 76420-053_b26ab5c7-62e8-3fc4-e053-2a95a90abb45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090682
Listing Expiration 2026-12-31
Marketing Start 2010-05-24

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 76420053
Hyphenated Format 76420-053

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

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 12 TABLET, FILM COATED in 1 BOTTLE (76420-053-12)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-053-30)
source: ndc

Packages (2)

76420-053-12 12 TABLET, FILM COATED in 1 BOTTLE (76420-053-12) 76420-053-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-053-30)

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": "b26ab5c7-62e8-3fc4-e053-2a95a90abb45", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["b99b8309-dd80-422a-9b17-f20386dc4d8d"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (76420-053-12)", "package_ndc": "76420-053-12", "marketing_start_date": "20201024"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-053-30)", "package_ndc": "76420-053-30", "marketing_start_date": "20201024"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "76420-053_b26ab5c7-62e8-3fc4-e053-2a95a90abb45", "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": "76420-053", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir Hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090682", "marketing_category": "ANDA", "marketing_start_date": "20100524", "listing_expiration_date": "20261231"}