valganciclovir hydrochloride

Generic: valganciclovir

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir hydrochloride
Generic Name valganciclovir
Labeler somerset therapeutics, llc
Dosage Form FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir 50 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-810
Product ID 70069-810_48f8965d-d9ca-7c96-e063-6394a90af350
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213306
Listing Expiration 2027-12-31
Marketing Start 2022-01-15

Pharmacologic Class

Established (EPC)
cytomegalovirus nucleoside analog dna polymerase inhibitor [epc]
Mechanism of Action
dna polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069810
Hyphenated Format 70069-810

Supplemental Identifiers

RxCUI
863559
UPC
0370069810019
UNII
GCU97FKN3R
NUI
N0000175461 N0000020060 N0000175459

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 (source: ndc)
Generic Name valganciclovir (source: ndc)
Application Number ANDA213306 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (70069-810-01)
source: ndc

Packages (1)

70069-810-01 100 mL in 1 BOTTLE (70069-810-01)

Ingredients (1)

valganciclovir (50 mg/mL)

Linked Drug Pages (1)

VALGANCICLOVIR HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48f8965d-d9ca-7c96-e063-6394a90af350", "openfda": {"nui": ["N0000175461", "N0000020060", "N0000175459"], "upc": ["0370069810019"], "unii": ["GCU97FKN3R"], "rxcui": ["863559"], "spl_set_id": ["b856bfaf-ec6b-4171-81c4-b9b07f780084"], "pharm_class_epc": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (70069-810-01)", "package_ndc": "70069-810-01", "marketing_start_date": "20220115"}], "brand_name": "VALGANCICLOVIR HYDROCHLORIDE", "product_id": "70069-810_48f8965d-d9ca-7c96-e063-6394a90af350", "dosage_form": "FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog [EXT]"], "product_ndc": "70069-810", "generic_name": "VALGANCICLOVIR", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALGANCICLOVIR HYDROCHLORIDE", "active_ingredients": [{"name": "VALGANCICLOVIR", "strength": "50 mg/mL"}], "application_number": "ANDA213306", "marketing_category": "ANDA", "marketing_start_date": "20220115", "listing_expiration_date": "20271231"}