valacyclovir

Generic: valacyclovir

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1000 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8705
Product ID 68788-8705_b4046250-4f62-4395-8cd0-cdd31edca208
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209553
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

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 687888705
Hyphenated Format 68788-8705

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
  • 6 TABLET in 1 BOTTLE (68788-8705-0)
  • 10 TABLET in 1 BOTTLE (68788-8705-1)
  • 20 TABLET in 1 BOTTLE (68788-8705-2)
  • 30 TABLET in 1 BOTTLE (68788-8705-3)
  • 4 TABLET in 1 BOTTLE (68788-8705-4)
  • 15 TABLET in 1 BOTTLE (68788-8705-5)
  • 21 TABLET in 1 BOTTLE (68788-8705-7)
source: ndc

Packages (7)

68788-8705-0 6 TABLET in 1 BOTTLE (68788-8705-0) 68788-8705-1 10 TABLET in 1 BOTTLE (68788-8705-1) 68788-8705-2 20 TABLET in 1 BOTTLE (68788-8705-2) 68788-8705-3 30 TABLET in 1 BOTTLE (68788-8705-3) 68788-8705-4 4 TABLET in 1 BOTTLE (68788-8705-4) 68788-8705-5 15 TABLET in 1 BOTTLE (68788-8705-5) 68788-8705-7 21 TABLET in 1 BOTTLE (68788-8705-7)

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": "b4046250-4f62-4395-8cd0-cdd31edca208", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313564"], "spl_set_id": ["3146e367-8438-4141-9368-95ce6f59c724"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE (68788-8705-0)", "package_ndc": "68788-8705-0", "marketing_start_date": "20240701"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (68788-8705-1)", "package_ndc": "68788-8705-1", "marketing_start_date": "20240701"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-8705-2)", "package_ndc": "68788-8705-2", "marketing_start_date": "20240701"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8705-3)", "package_ndc": "68788-8705-3", "marketing_start_date": "20240701"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE (68788-8705-4)", "package_ndc": "68788-8705-4", "marketing_start_date": "20240701"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (68788-8705-5)", "package_ndc": "68788-8705-5", "marketing_start_date": "20240701"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (68788-8705-7)", "package_ndc": "68788-8705-7", "marketing_start_date": "20240701"}], "brand_name": "Valacyclovir", "product_id": "68788-8705_b4046250-4f62-4395-8cd0-cdd31edca208", "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": "68788-8705", "generic_name": "Valacyclovir", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20240701", "listing_expiration_date": "20261231"}