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, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
Direct Rx

Identifiers & Regulatory

Product NDC 61919-066
Product ID 61919-066_364a2f8b-adfa-b8ce-e063-6394a90a8f9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201506
Listing Expiration 2026-12-31
Marketing Start 2015-01-01

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 61919066
Hyphenated Format 61919-066

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 ANDA201506 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (61919-066-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE (61919-066-60)
source: ndc

Packages (2)

61919-066-20 20 TABLET, FILM COATED in 1 BOTTLE (61919-066-20) 61919-066-60 60 TABLET, FILM COATED in 1 BOTTLE (61919-066-60)

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": "364a2f8b-adfa-b8ce-e063-6394a90a8f9d", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["cbd7bb49-7a9c-4383-a158-bfc307db0130"], "manufacturer_name": ["Direct Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (61919-066-20)", "package_ndc": "61919-066-20", "marketing_start_date": "20150101"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (61919-066-60)", "package_ndc": "61919-066-60", "marketing_start_date": "20150101"}], "brand_name": "Valacyclovir", "product_id": "61919-066_364a2f8b-adfa-b8ce-e063-6394a90a8f9d", "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": "61919-066", "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": "ANDA201506", "marketing_category": "ANDA", "marketing_start_date": "20150101", "listing_expiration_date": "20261231"}