valganciclovir hydrochloride for oral

Generic: valganciclovir hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir hydrochloride for oral
Generic Name valganciclovir hydrochloride
Labeler actavis pharma, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2579
Product ID 0591-2579_9f669f81-9b46-440d-bb4f-0696098da2cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205220
Listing Expiration 2026-12-31
Marketing Start 2016-08-26

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 05912579
Hyphenated Format 0591-2579

Supplemental Identifiers

RxCUI
863559
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 valganciclovir hydrochloride for oral (source: ndc)
Generic Name valganciclovir hydrochloride (source: ndc)
Application Number ANDA205220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE, GLASS (0591-2579-20)
source: ndc

Packages (1)

0591-2579-20 100 mL in 1 BOTTLE, GLASS (0591-2579-20)

Ingredients (1)

valganciclovir hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Valganciclovir hydrochloride for Oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9f669f81-9b46-440d-bb4f-0696098da2cc", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["92281301-5fb5-4eea-8766-4863e241c234"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE, GLASS (0591-2579-20)", "package_ndc": "0591-2579-20", "marketing_start_date": "20160826"}], "brand_name": "Valganciclovir hydrochloride for Oral", "product_id": "0591-2579_9f669f81-9b46-440d-bb4f-0696098da2cc", "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": "0591-2579", "generic_name": "Valganciclovir hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir hydrochloride for Oral", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA205220", "marketing_category": "ANDA", "marketing_start_date": "20160826", "listing_expiration_date": "20261231"}