valacyclovir

Generic: valacyclovir

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-630
Product ID 72189-630_3c6c3546-b4a4-1f0e-e063-6394a90a8c29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209553
Listing Expiration 2026-12-31
Marketing Start 2025-06-26

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 72189630
Hyphenated Format 72189-630

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

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (72189-630-20)
  • 20 TABLET in 1 BOTTLE (72189-630-30)
source: ndc

Packages (2)

72189-630-20 20 TABLET in 1 BOTTLE (72189-630-20) 72189-630-30 20 TABLET in 1 BOTTLE (72189-630-30)

Ingredients (1)

valacyclovir hydrochloride (500 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": "3c6c3546-b4a4-1f0e-e063-6394a90a8c29", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["387c9c12-4735-1f9d-e063-6394a90a030c"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (72189-630-20)", "package_ndc": "72189-630-20", "marketing_start_date": "20250626"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (72189-630-30)", "package_ndc": "72189-630-30", "marketing_start_date": "20250626"}], "brand_name": "Valacyclovir", "product_id": "72189-630_3c6c3546-b4a4-1f0e-e063-6394a90a8c29", "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": "72189-630", "generic_name": "Valacyclovir", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209553", "marketing_category": "ANDA", "marketing_start_date": "20250626", "listing_expiration_date": "20261231"}