valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir hydrochloride
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3037
Product ID 68071-3037_1d8e280d-fb14-0e85-e063-6294a90a17a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077135
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 680713037
Hyphenated Format 68071-3037

Supplemental Identifiers

RxCUI
313565
UPC
0368071303735
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 ANDA077135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (68071-3037-1)
  • 12 TABLET in 1 BOTTLE (68071-3037-2)
  • 8 TABLET in 1 BOTTLE (68071-3037-8)
source: ndc

Packages (3)

68071-3037-1 10 TABLET in 1 BOTTLE (68071-3037-1) 68071-3037-2 12 TABLET in 1 BOTTLE (68071-3037-2) 68071-3037-8 8 TABLET in 1 BOTTLE (68071-3037-8)

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": "1d8e280d-fb14-0e85-e063-6294a90a17a9", "openfda": {"upc": ["0368071303735"], "unii": ["G447S0T1VC"], "rxcui": ["313565"], "spl_set_id": ["49db4bcd-8b5a-048d-e054-00144ff88e88"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68071-3037-1)", "package_ndc": "68071-3037-1", "marketing_start_date": "20170303"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (68071-3037-2)", "package_ndc": "68071-3037-2", "marketing_start_date": "20170303"}, {"sample": false, "description": "8 TABLET in 1 BOTTLE (68071-3037-8)", "package_ndc": "68071-3037-8", "marketing_start_date": "20170303"}], "brand_name": "Valacyclovir hydrochloride", "product_id": "68071-3037_1d8e280d-fb14-0e85-e063-6294a90a17a9", "dosage_form": "TABLET", "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": "68071-3037", "generic_name": "Valacyclovir hydrochloride", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077135", "marketing_category": "ANDA", "marketing_start_date": "20100524", "listing_expiration_date": "20261231"}