valganciclovir hydrochloride for oral (42291-972)

Drug Facts

Product Profile

Brand Name valganciclovir hydrochloride for oral

Generic Name valganciclovir hydrochloride

Labeler avkare

Dosage Form POWDER, FOR SOLUTION

Routes

ORAL

Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-972

Product ID 42291-972_48c2d3e0-cf43-2438-e063-6294a90a9557

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205220

Listing Expiration 2027-12-31

Marketing Start 2023-10-17

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 42291972

Hyphenated Format 42291-972

Supplemental Identifiers

RxCUI

863559

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 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 (42291-972-01)

source: ndc

Packages (1)

42291-972-01 100 mL in 1 BOTTLE (42291-972-01)

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": "48c2d3e0-cf43-2438-e063-6294a90a9557", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["07eb5abf-2322-4fb9-e063-6394a90a2311"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (42291-972-01)", "package_ndc": "42291-972-01", "marketing_start_date": "20231017"}], "brand_name": "Valganciclovir hydrochloride for Oral", "product_id": "42291-972_48c2d3e0-cf43-2438-e063-6294a90a9557", "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": "42291-972", "generic_name": "Valganciclovir hydrochloride", "labeler_name": "AvKARE", "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": "20231017", "listing_expiration_date": "20271231"}