valganciclovir

Generic: valganciclovir

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-965
Product ID 68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203511
Listing Expiration 2026-12-31
Marketing Start 2015-01-07

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 68084965
Hyphenated Format 68084-965

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 (source: ndc)
Application Number ANDA203511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (68084-965-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18)
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95)
source: ndc

Packages (2)

68084-965-19 20 BLISTER PACK in 1 CARTON (68084-965-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18) 68084-965-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95)

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": "22ca12d3-7404-28f7-e063-6394a90a94bf", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["4db6dd63-e56b-45a4-86b2-ee125a1854a0"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (68084-965-19)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18)", "package_ndc": "68084-965-19", "marketing_start_date": "20240922"}, {"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95)", "package_ndc": "68084-965-25", "marketing_start_date": "20150116"}], "brand_name": "Valganciclovir", "product_id": "68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf", "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": "68084-965", "generic_name": "Valganciclovir", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA203511", "marketing_category": "ANDA", "marketing_start_date": "20150107", "listing_expiration_date": "20261231"}