valganciclovir hydrochloride

Generic: valganciclovir hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

valganciclovir hydrochloride 50 mg/mL

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-7419
Product ID 0904-7419_35e1c8f8-af47-4866-b5d8-b1ce197cece0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210169
Marketing Start 2022-02-17
Marketing End 2026-05-30

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 09047419
Hyphenated Format 0904-7419

Supplemental Identifiers

RxCUI
863559
UPC
0309047419043
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 (0904-7419-04) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

0904-7419-04 1 BOTTLE in 1 CARTON (0904-7419-04) / 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": "35e1c8f8-af47-4866-b5d8-b1ce197cece0", "openfda": {"upc": ["0309047419043"], "unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["f656a741-7f9c-4173-8893-c259b0d96f5b"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-7419-04)  / 100 mL in 1 BOTTLE", "package_ndc": "0904-7419-04", "marketing_end_date": "20260530", "marketing_start_date": "20240105"}], "brand_name": "valganciclovir hydrochloride", "product_id": "0904-7419_35e1c8f8-af47-4866-b5d8-b1ce197cece0", "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": "0904-7419", "generic_name": "valganciclovir hydrochloride", "labeler_name": "MAJOR PHARMACEUTICALS", "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_end_date": "20260530", "marketing_start_date": "20220217"}