valganciclovir

Generic: valganciclovir hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir hydrochloride
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-973
Product ID 42291-973_48c2e236-ce58-2ce4-e063-6294a90af3ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200790
Listing Expiration 2027-12-31
Marketing Start 2023-12-21

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 42291973
Hyphenated Format 42291-973

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 hydrochloride (source: ndc)
Application Number ANDA200790 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (42291-973-60)
source: ndc

Packages (1)

42291-973-60 60 TABLET, FILM COATED in 1 BOTTLE (42291-973-60)

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": "48c2e236-ce58-2ce4-e063-6294a90af3ae", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["0d0bbc91-27f6-29bc-e063-6394a90a0027"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (42291-973-60)", "package_ndc": "42291-973-60", "marketing_start_date": "20231221"}], "brand_name": "Valganciclovir", "product_id": "42291-973_48c2e236-ce58-2ce4-e063-6294a90af3ae", "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": "42291-973", "generic_name": "Valganciclovir hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA200790", "marketing_category": "ANDA", "marketing_start_date": "20231221", "listing_expiration_date": "20271231"}