valganciclovir

Generic: valganciclovir

Labeler: airis pharma pvt ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir
Labeler airis pharma pvt ltd
Dosage Form FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer
airis PHARMA PVT LTD

Identifiers & Regulatory

Product NDC 71151-003
Product ID 71151-003_d94fb558-d963-5c7a-e053-2a95a90a04b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210169
Listing Expiration 2026-12-31
Marketing Start 2022-02-28

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 71151003
Hyphenated Format 71151-003

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 (source: ndc)
Application Number ANDA210169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE, DISPENSING (71151-003-01)
source: ndc

Packages (1)

71151-003-01 100 mL in 1 BOTTLE, DISPENSING (71151-003-01)

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": "d94fb558-d963-5c7a-e053-2a95a90a04b4", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["ddfb4e0e-64f5-4654-8670-91b8b6abe794"], "manufacturer_name": ["airis PHARMA PVT LTD"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE, DISPENSING (71151-003-01)", "package_ndc": "71151-003-01", "marketing_start_date": "20220228"}], "brand_name": "VALGANCICLOVIR", "product_id": "71151-003_d94fb558-d963-5c7a-e053-2a95a90a04b4", "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": "71151-003", "generic_name": "valganciclovir", "labeler_name": "airis PHARMA PVT LTD", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALGANCICLOVIR", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA210169", "marketing_category": "ANDA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}