valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

valacyclovir hydrochloride 1 g/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-789
Product ID 50268-789_4138ca20-b94f-bdfd-e063-6294a90aa9d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090682
Listing Expiration 2026-12-31
Marketing Start 2014-09-22

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 50268789
Hyphenated Format 50268-789

Supplemental Identifiers

RxCUI
313564 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
  • 1 g/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-789-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-789-11)
source: ndc

Packages (1)

50268-789-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-789-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-789-11)

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": "4138ca20-b94f-bdfd-e063-6294a90aa9d4", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["7f5fc62f-d043-db36-ce92-7adc4f7a79a5"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-789-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-789-11)", "package_ndc": "50268-789-15", "marketing_start_date": "20140922"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "50268-789_4138ca20-b94f-bdfd-e063-6294a90aa9d4", "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": "50268-789", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "AvPAK", "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": "20140922", "listing_expiration_date": "20261231"}