valganciclovir

Generic: valganciclovir hydrochloride

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir hydrochloride
Labeler strides pharma science limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-161
Product ID 64380-161_058fa4c8-4170-4506-a930-dcacb28d9eff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200790
Listing Expiration 2026-12-31
Marketing Start 2025-06-16

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 64380161
Hyphenated Format 64380-161

Supplemental Identifiers

RxCUI
313566
UPC
0364380161011
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 (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, PLASTIC (64380-161-01)
source: ndc

Packages (1)

64380-161-01 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-161-01)

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": "058fa4c8-4170-4506-a930-dcacb28d9eff", "openfda": {"upc": ["0364380161011"], "unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["89a934f0-85a3-44c1-82e5-d09d1738e08d"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-161-01)", "package_ndc": "64380-161-01", "marketing_start_date": "20250616"}], "brand_name": "Valganciclovir", "product_id": "64380-161_058fa4c8-4170-4506-a930-dcacb28d9eff", "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": "64380-161", "generic_name": "Valganciclovir hydrochloride", "labeler_name": "Strides Pharma Science Limited", "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": "20250616", "listing_expiration_date": "20261231"}