valganciclovir hydrochloride

Generic: valganciclovir hydrochloride

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir hydrochloride
Generic Name valganciclovir hydrochloride
Labeler novadoz pharmaceuticals llc
Dosage Form FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-019
Product ID 72205-019_614ff447-7e5f-4ea6-ba85-ec1f6497b360
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210169
Listing Expiration 2026-12-31
Marketing Start 2022-02-17

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 72205019
Hyphenated Format 72205-019

Supplemental Identifiers

RxCUI
863559
UPC
0372205019010
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 hydrochloride (source: ndc)
Generic Name valganciclovir hydrochloride (source: ndc)
Application Number ANDA210169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72205-019-01) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

72205-019-01 1 BOTTLE in 1 CARTON (72205-019-01) / 100 mL in 1 BOTTLE

Ingredients (1)

valganciclovir hydrochloride (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": "614ff447-7e5f-4ea6-ba85-ec1f6497b360", "openfda": {"upc": ["0372205019010"], "unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["614ff447-7e5f-4ea6-ba85-ec1f6497b360"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72205-019-01)  / 100 mL in 1 BOTTLE", "package_ndc": "72205-019-01", "marketing_start_date": "20220914"}], "brand_name": "valganciclovir hydrochloride", "product_id": "72205-019_614ff447-7e5f-4ea6-ba85-ec1f6497b360", "dosage_form": "FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "72205-019", "generic_name": "valganciclovir hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "valganciclovir hydrochloride", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA210169", "marketing_category": "ANDA", "marketing_start_date": "20220217", "listing_expiration_date": "20261231"}