valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1 g/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-538
Product ID 63187-538_0ac3f14c-c375-408e-a1d7-8412e3420a40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201506
Listing Expiration 2026-12-31
Marketing Start 2012-04-05

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 63187538
Hyphenated Format 63187-538

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 hydrochloride (source: ndc)
Generic Name valacyclovir hydrochloride (source: ndc)
Application Number ANDA201506 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04)
  • 14 TABLET, FILM COATED in 1 BOTTLE (63187-538-14)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-538-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-538-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-538-90)
source: ndc

Packages (5)

63187-538-04 4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04) 63187-538-14 14 TABLET, FILM COATED in 1 BOTTLE (63187-538-14) 63187-538-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-538-30) 63187-538-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-538-60) 63187-538-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-538-90)

Ingredients (1)

valacyclovir hydrochloride (1 g/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": "0ac3f14c-c375-408e-a1d7-8412e3420a40", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313564"], "spl_set_id": ["efe37bd1-a236-43cc-828c-b57e8a704d67"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04)", "package_ndc": "63187-538-04", "marketing_start_date": "20150901"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (63187-538-14)", "package_ndc": "63187-538-14", "marketing_start_date": "20150901"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-538-30)", "package_ndc": "63187-538-30", "marketing_start_date": "20150901"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-538-60)", "package_ndc": "63187-538-60", "marketing_start_date": "20150901"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-538-90)", "package_ndc": "63187-538-90", "marketing_start_date": "20150901"}], "brand_name": "valacyclovir hydrochloride", "product_id": "63187-538_0ac3f14c-c375-408e-a1d7-8412e3420a40", "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": "63187-538", "generic_name": "valacyclovir hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "valacyclovir hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA201506", "marketing_category": "ANDA", "marketing_start_date": "20120405", "listing_expiration_date": "20261231"}