valganciclovir

Generic: valganciclovir

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-832
Product ID 31722-832_2b44d151-5b10-9250-e063-6294a90a53c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205166
Listing Expiration 2026-12-31
Marketing Start 2016-03-18

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 31722832
Hyphenated Format 31722-832

Supplemental Identifiers

RxCUI
313566
UPC
0331722832601
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 ANDA205166 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-832-31)
  • 10 TABLET, FILM COATED in 1 CARTON (31722-832-32)
  • 60 TABLET, FILM COATED in 1 BOTTLE (31722-832-60)
source: ndc

Packages (3)

31722-832-31 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-832-31) 31722-832-32 10 TABLET, FILM COATED in 1 CARTON (31722-832-32) 31722-832-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-832-60)

Ingredients (1)

valganciclovir hydrochloride (450 mg/1)

Linked Drug Pages (1)

Valganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b44d151-5b10-9250-e063-6294a90a53c2", "openfda": {"upc": ["0331722832601"], "unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["383e8810-b877-4a4f-abdf-c8c4c8e394f8"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (31722-832-31)", "package_ndc": "31722-832-31", "marketing_start_date": "20160318"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 CARTON (31722-832-32)", "package_ndc": "31722-832-32", "marketing_start_date": "20160318"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-832-60)", "package_ndc": "31722-832-60", "marketing_start_date": "20160318"}], "brand_name": "Valganciclovir", "product_id": "31722-832_2b44d151-5b10-9250-e063-6294a90a53c2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "31722-832", "generic_name": "Valganciclovir", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA205166", "marketing_category": "ANDA", "marketing_start_date": "20160318", "listing_expiration_date": "20261231"}