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 1000 mg/1

Manufacturer
Direct _Rx

Identifiers & Regulatory

Product NDC 72189-594
Product ID 72189-594_410c1df4-2156-d672-e063-6394a90ab376
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209553
Listing Expiration 2026-12-31
Marketing Start 2024-11-11

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 72189594
Hyphenated Format 72189-594

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 (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
  • 4 TABLET in 1 BOTTLE (72189-594-04)
  • 16 TABLET in 1 BOTTLE (72189-594-16)
  • 21 TABLET in 1 BOTTLE (72189-594-21)
  • 30 TABLET in 1 BOTTLE (72189-594-30)
source: ndc

Packages (4)

72189-594-04 4 TABLET in 1 BOTTLE (72189-594-04) 72189-594-16 16 TABLET in 1 BOTTLE (72189-594-16) 72189-594-21 21 TABLET in 1 BOTTLE (72189-594-21) 72189-594-30 30 TABLET in 1 BOTTLE (72189-594-30)

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": "410c1df4-2156-d672-e063-6394a90ab376", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313564"], "spl_set_id": ["26a43531-c62a-9e7f-e063-6394a90a8d3f"], "manufacturer_name": ["Direct _Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE (72189-594-04)", "package_ndc": "72189-594-04", "marketing_start_date": "20241111"}, {"sample": false, "description": "16 TABLET in 1 BOTTLE (72189-594-16)", "package_ndc": "72189-594-16", "marketing_start_date": "20241111"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (72189-594-21)", "package_ndc": "72189-594-21", "marketing_start_date": "20241111"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-594-30)", "package_ndc": "72189-594-30", "marketing_start_date": "20241111"}], "brand_name": "Valacyclovir", "product_id": "72189-594_410c1df4-2156-d672-e063-6394a90ab376", "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": "72189-594", "generic_name": "Valacyclovir", "labeler_name": "Direct _Rx", "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": "20241111", "listing_expiration_date": "20261231"}