valcyte

Generic: valganciclovir

Labeler: h2-pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name valcyte
Generic Name valganciclovir
Labeler h2-pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-480
Product ID 61269-480_c70cbfa5-6b69-4fd4-8ad0-e819c8795746
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021304
Listing Expiration 2026-12-31
Marketing Start 2001-03-29

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 61269480
Hyphenated Format 61269-480

Supplemental Identifiers

RxCUI
284587 313566 863559 863562
UNII
4P3T9QF9NZ

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 valcyte (source: ndc)
Generic Name valganciclovir (source: ndc)
Application Number NDA021304 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

61269-480-60 1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

valganciclovir hydrochloride (450 mg/1)

Linked Drug Pages (1)

Valcyte ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c70cbfa5-6b69-4fd4-8ad0-e819c8795746", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["284587", "313566", "863559", "863562"], "spl_set_id": ["4c517a39-2ded-4c5a-8d56-276853414b31"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60)  / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "61269-480-60", "marketing_start_date": "20010329"}], "brand_name": "Valcyte", "product_id": "61269-480_c70cbfa5-6b69-4fd4-8ad0-e819c8795746", "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": "61269-480", "generic_name": "valganciclovir", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valcyte", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "NDA021304", "marketing_category": "NDA", "marketing_start_date": "20010329", "listing_expiration_date": "20261231"}