valganciclovir

Generic: valganciclovir

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-787
Product ID 50268-787_4745ad6c-8db3-18af-e063-6394a90a0814
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205166
Listing Expiration 2026-12-31
Marketing Start 2016-07-27

Pharmacologic Class

Classes
cytomegalovirus nucleoside analog dna polymerase inhibitor [epc] dna polymerase inhibitors [moa] nucleoside analog antiviral [epc] nucleoside analog [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268787
Hyphenated Format 50268-787

Supplemental Identifiers

RxCUI
313566
UNII
4P3T9QF9NZ

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 valganciclovir (source: ndc)
Generic Name valganciclovir (source: ndc)
Application Number ANDA205166 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-787-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-787-11)
source: ndc

Packages (1)

50268-787-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-787-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-787-11)

Ingredients (1)

valganciclovir hydrochloride (450 mg/1)

Linked Drug Pages (1)

Valganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4745ad6c-8db3-18af-e063-6394a90a0814", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["85177859-e0f5-6d83-17f3-29cae1db96c3"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-787-12)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-787-11)", "package_ndc": "50268-787-12", "marketing_start_date": "20160727"}], "brand_name": "Valganciclovir", "product_id": "50268-787_4745ad6c-8db3-18af-e063-6394a90a0814", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "50268-787", "generic_name": "Valganciclovir", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA205166", "marketing_category": "ANDA", "marketing_start_date": "20160727", "listing_expiration_date": "20261231"}