valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-730
Product ID 43063-730_414b28cc-0de6-e201-e063-6294a90addbf
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 43063730
Hyphenated Format 43063-730

Supplemental Identifiers

RxCUI
313565
UPC
0343063730904
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, PLASTIC (43063-730-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-14)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-90)
source: ndc

Packages (3)

43063-730-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-10) 43063-730-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-14) 43063-730-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-90)

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": "414b28cc-0de6-e201-e063-6294a90addbf", "openfda": {"upc": ["0343063730904"], "unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["1a888812-2867-4dd3-b56e-2d98da837d1f"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-10)", "package_ndc": "43063-730-10", "marketing_start_date": "20170119"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-14)", "package_ndc": "43063-730-14", "marketing_start_date": "20161129"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-90)", "package_ndc": "43063-730-90", "marketing_start_date": "20190208"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "43063-730_414b28cc-0de6-e201-e063-6294a90addbf", "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": "43063-730", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}