valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

valacyclovir hydrochloride 500 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-698
Product ID 16714-698_086d34eb-21bb-4159-80c3-8e64eda1b6e5
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 16714698
Hyphenated Format 16714-698

Supplemental Identifiers

RxCUI
313564 313565
UPC
0316714697031
UNII
G447S0T1VC

Packaging Origin

Original Packager
true

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
  • 90 TABLET, FILM COATED in 1 BOTTLE (16714-698-03)
source: ndc

Packages (1)

16714-698-03 90 TABLET, FILM COATED in 1 BOTTLE (16714-698-03)

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": "086d34eb-21bb-4159-80c3-8e64eda1b6e5", "openfda": {"upc": ["0316714697031"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["4acf51de-26f7-42b2-8acc-61b800627ef3"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16714-698-03)", "package_ndc": "16714-698-03", "marketing_start_date": "20100524"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "16714-698_086d34eb-21bb-4159-80c3-8e64eda1b6e5", "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": "16714-698", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "NorthStar Rx LLC", "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"}