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 72789-264
Product ID 72789-264_4bace65f-2eb6-8f0f-e063-6394a90a0b11
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 72789264
Hyphenated Format 72789-264

Supplemental Identifiers

RxCUI
313565
UPC
0372789264301
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
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-264-30)
source: ndc

Packages (1)

72789-264-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-264-30)

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": "4bace65f-2eb6-8f0f-e063-6394a90a0b11", "openfda": {"upc": ["0372789264301"], "unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["e300970d-1145-4460-a8c8-f6e1654c2c3d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-264-30)", "package_ndc": "72789-264-30", "marketing_start_date": "20220722"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "72789-264_4bace65f-2eb6-8f0f-e063-6394a90a0b11", "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": "72789-264", "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"}