valganciclovir hydrochloride

Generic: valganciclovir hydrochloride

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

Drug Facts

Product Profile

Brand Name valganciclovir hydrochloride
Generic Name valganciclovir hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-753
Product ID 65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204750
Listing Expiration 2027-12-31
Marketing Start 2016-03-31

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 65862753
Hyphenated Format 65862-753

Supplemental Identifiers

RxCUI
313566
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 ANDA204750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-753-01)
  • 500 TABLET in 1 BOTTLE (65862-753-05)
  • 180 TABLET in 1 BOTTLE (65862-753-18)
  • 60 TABLET in 1 BOTTLE (65862-753-60)
  • 1000 TABLET in 1 BOTTLE (65862-753-99)
source: ndc

Packages (5)

65862-753-01 100 TABLET in 1 BOTTLE (65862-753-01) 65862-753-05 500 TABLET in 1 BOTTLE (65862-753-05) 65862-753-18 180 TABLET in 1 BOTTLE (65862-753-18) 65862-753-60 60 TABLET in 1 BOTTLE (65862-753-60) 65862-753-99 1000 TABLET in 1 BOTTLE (65862-753-99)

Ingredients (1)

valganciclovir hydrochloride (450 mg/1)

Linked Drug Pages (1)

VALGANCICLOVIR HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d5cd566-06ab-4e83-aba8-f692ff8a23dd", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad83"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-753-01)", "package_ndc": "65862-753-01", "marketing_start_date": "20160331"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-753-05)", "package_ndc": "65862-753-05", "marketing_start_date": "20160331"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (65862-753-18)", "package_ndc": "65862-753-18", "marketing_start_date": "20160331"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (65862-753-60)", "package_ndc": "65862-753-60", "marketing_start_date": "20160331"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-753-99)", "package_ndc": "65862-753-99", "marketing_start_date": "20160331"}], "brand_name": "VALGANCICLOVIR HYDROCHLORIDE", "product_id": "65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd", "dosage_form": "TABLET", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "65862-753", "generic_name": "VALGANCICLOVIR HYDROCHLORIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALGANCICLOVIR HYDROCHLORIDE", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA204750", "marketing_category": "ANDA", "marketing_start_date": "20160331", "listing_expiration_date": "20271231"}