valganciclovir

Generic: valganciclovir hydrochloride

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

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir hydrochloride
Labeler american health packaging
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-765
Product ID 60687-765_038956dc-dd87-2583-e063-6294a90aa282
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211475
Listing Expiration 2026-12-31
Marketing Start 2023-08-20

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 60687765
Hyphenated Format 60687-765

Supplemental Identifiers

RxCUI
863559
UPC
0360687765136
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 ANDA211475 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (60687-765-13) / 100 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

60687-765-13 1 BOTTLE, GLASS in 1 CARTON (60687-765-13) / 100 mL in 1 BOTTLE, GLASS

Ingredients (1)

valganciclovir hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Valganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "038956dc-dd87-2583-e063-6294a90aa282", "openfda": {"upc": ["0360687765136"], "unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["0e30509f-add6-43c8-9e1d-e10c55a207e6"], "manufacturer_name": ["American Health Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (60687-765-13)  / 100 mL in 1 BOTTLE, GLASS", "package_ndc": "60687-765-13", "marketing_start_date": "20230820"}], "brand_name": "Valganciclovir", "product_id": "60687-765_038956dc-dd87-2583-e063-6294a90aa282", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "60687-765", "generic_name": "Valganciclovir Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA211475", "marketing_category": "ANDA", "marketing_start_date": "20230820", "listing_expiration_date": "20261231"}