valcyte

Generic: valganciclovir hydrochloride

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

Drug Facts

Product Profile

Brand Name valcyte
Generic Name valganciclovir hydrochloride
Labeler h2-pharma, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-485
Product ID 61269-485_c70cbfa5-6b69-4fd4-8ad0-e819c8795746
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022257
Listing Expiration 2026-12-31
Marketing Start 2009-08-28

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 61269485
Hyphenated Format 61269-485

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 hydrochloride (source: ndc)
Application Number NDA022257 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

61269-485-10 1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS

Ingredients (1)

valganciclovir hydrochloride (50 mg/mL)

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, GLASS in 1 CARTON (61269-485-10)  / 100 mL in 1 BOTTLE, GLASS", "package_ndc": "61269-485-10", "marketing_start_date": "20090828"}], "brand_name": "Valcyte", "product_id": "61269-485_c70cbfa5-6b69-4fd4-8ad0-e819c8795746", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "61269-485", "generic_name": "valganciclovir hydrochloride", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valcyte", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "NDA022257", "marketing_category": "NDA", "marketing_start_date": "20090828", "listing_expiration_date": "20261231"}