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 72789-263
Product ID 72789-263_4bace031-383a-f25c-e063-6294a90a27da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090682
Listing Expiration 2027-12-31
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 72789263
Hyphenated Format 72789-263

Supplemental Identifiers

RxCUI
313565
UPC
0372789263281
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
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-06)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-14)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-28)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-90)
source: ndc

Packages (5)

72789-263-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-06) 72789-263-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-10) 72789-263-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-14) 72789-263-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-28) 72789-263-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-90)

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": "4bace031-383a-f25c-e063-6294a90a27da", "openfda": {"upc": ["0372789263281"], "unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["ae8d15a4-1ed5-4e3c-9672-0f4735322a1c"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-06)", "package_ndc": "72789-263-06", "marketing_start_date": "20250618"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-10)", "package_ndc": "72789-263-10", "marketing_start_date": "20221011"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-14)", "package_ndc": "72789-263-14", "marketing_start_date": "20231204"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-28)", "package_ndc": "72789-263-28", "marketing_start_date": "20250303"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-90)", "package_ndc": "72789-263-90", "marketing_start_date": "20220720"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "72789-263_4bace031-383a-f25c-e063-6294a90a27da", "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": "72789-263", "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": "20271231"}