Package 64380-161-01
Brand: valganciclovir
Generic: valganciclovir hydrochloridePackage Facts
Identity
Package NDC
64380-161-01
Digits Only
6438016101
Product NDC
64380-161
Description
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-161-01)
Marketing
Marketing Status
Brand
valganciclovir
Generic
valganciclovir hydrochloride
Sample Package
No
Linked Drug Pages (1)
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"}