valganciclovir

Generic: valganciclovir

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

valganciclovir hydrochloride 450 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6796
Product ID 0904-6796_cab8eef9-3094-4824-a5a6-3e11cd06853c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205166
Listing Expiration 2026-12-31
Marketing Start 2016-03-18

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 09046796
Hyphenated Format 0904-6796

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
  • 30 BLISTER PACK in 1 CARTON (0904-6796-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (0904-6796-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0904-6796-04 30 BLISTER PACK in 1 CARTON (0904-6796-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-6796-10 20 BLISTER PACK in 1 CARTON (0904-6796-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "cab8eef9-3094-4824-a5a6-3e11cd06853c", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["6a6533fd-0579-4059-ba87-aa399829a8b0"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6796-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6796-04", "marketing_start_date": "20160318"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0904-6796-10)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6796-10", "marketing_start_date": "20160318"}], "brand_name": "Valganciclovir", "product_id": "0904-6796_cab8eef9-3094-4824-a5a6-3e11cd06853c", "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": "0904-6796", "generic_name": "Valganciclovir", "labeler_name": "Major Pharmaceuticals", "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": "20160318", "listing_expiration_date": "20261231"}