valganciclovir

Generic: valganciclovir hydrochloride powder,

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir hydrochloride powder,
Labeler aurobindo pharma limited
Dosage Form FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-444
Product ID 59651-444_a1e3ad22-5bc8-45a1-9a9b-1305533be169
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215124
Listing Expiration 2027-12-31
Marketing Start 2022-11-17

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 59651444
Hyphenated Format 59651-444

Supplemental Identifiers

RxCUI
863559
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 powder, (source: ndc)
Application Number ANDA215124 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (59651-444-01) / 100 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

59651-444-01 1 BOTTLE, GLASS in 1 CARTON (59651-444-01) / 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": "a1e3ad22-5bc8-45a1-9a9b-1305533be169", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["1e08a87f-624a-4993-a773-8c660c27b6af"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (59651-444-01)  / 100 mL in 1 BOTTLE, GLASS", "package_ndc": "59651-444-01", "marketing_start_date": "20221117"}], "brand_name": "Valganciclovir", "product_id": "59651-444_a1e3ad22-5bc8-45a1-9a9b-1305533be169", "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": "59651-444", "generic_name": "Valganciclovir hydrochloride powder,", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA215124", "marketing_category": "ANDA", "marketing_start_date": "20221117", "listing_expiration_date": "20271231"}