valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5852
Product ID 50090-5852_083acc4f-83b4-42c8-8d6c-8786375d6c0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090682
Listing Expiration 2026-12-31
Marketing Start 2010-05-24

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 500905852
Hyphenated Format 50090-5852

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 hydrochloride (source: ndc)
Generic Name valacyclovir hydrochloride (source: ndc)
Application Number ANDA090682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-5852-0)
  • 14 TABLET, FILM COATED in 1 BOTTLE (50090-5852-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-5852-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-5852-3)
source: ndc

Packages (4)

50090-5852-0 10 TABLET, FILM COATED in 1 BOTTLE (50090-5852-0) 50090-5852-1 14 TABLET, FILM COATED in 1 BOTTLE (50090-5852-1) 50090-5852-2 30 TABLET, FILM COATED in 1 BOTTLE (50090-5852-2) 50090-5852-3 90 TABLET, FILM COATED in 1 BOTTLE (50090-5852-3)

Ingredients (1)

valacyclovir hydrochloride (500 mg/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": "083acc4f-83b4-42c8-8d6c-8786375d6c0f", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["df34e11d-5f2c-4755-b84b-b95d1d7b73f0"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (50090-5852-0)", "package_ndc": "50090-5852-0", "marketing_start_date": "20211110"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (50090-5852-1)", "package_ndc": "50090-5852-1", "marketing_start_date": "20211110"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5852-2)", "package_ndc": "50090-5852-2", "marketing_start_date": "20211110"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5852-3)", "package_ndc": "50090-5852-3", "marketing_start_date": "20211110"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "50090-5852_083acc4f-83b4-42c8-8d6c-8786375d6c0f", "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": "50090-5852", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir Hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090682", "marketing_category": "ANDA", "marketing_start_date": "20100524", "listing_expiration_date": "20261231"}