valacyclovir

Generic: valacyclovir hydrochloride

Labeler: yiling pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

valacyclovir hydrochloride 1 g/1

Manufacturer
Yiling Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 69117-0011
Product ID 69117-0011_47237b45-ce93-292b-e063-6394a90a1ab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209553
Listing Expiration 2026-12-31
Marketing Start 2018-10-01

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 691170011
Hyphenated Format 69117-0011

Supplemental Identifiers

RxCUI
313564 313565
UPC
0369117001011 0369117001127 0369117001110 0369117001134
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 (source: ndc)
Generic Name valacyclovir hydrochloride (source: ndc)
Application Number ANDA209553 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69117-0011-1)
  • 90 TABLET in 1 BOTTLE (69117-0011-2)
  • 500 TABLET in 1 BOTTLE (69117-0011-3)
source: ndc

Packages (3)

69117-0011-1 30 TABLET in 1 BOTTLE (69117-0011-1) 69117-0011-2 90 TABLET in 1 BOTTLE (69117-0011-2) 69117-0011-3 500 TABLET in 1 BOTTLE (69117-0011-3)

Ingredients (1)

valacyclovir hydrochloride (1 g/1)

Linked Drug Pages (1)

Valacyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47237b45-ce93-292b-e063-6394a90a1ab5", "openfda": {"upc": ["0369117001011", "0369117001127", "0369117001110", "0369117001134"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["f3ee4017-a4fc-475d-a49b-b39168ec5966"], "manufacturer_name": ["Yiling Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69117-0011-1)", "package_ndc": "69117-0011-1", "marketing_start_date": "20181001"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69117-0011-2)", "package_ndc": "69117-0011-2", "marketing_start_date": "20181001"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69117-0011-3)", "package_ndc": "69117-0011-3", "marketing_start_date": "20181001"}], "brand_name": "Valacyclovir", "product_id": "69117-0011_47237b45-ce93-292b-e063-6394a90a1ab5", "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": "69117-0011", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "Yiling Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA209553", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}