valganciclovir

Generic: valganciclovir

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir
Labeler ajanta pharma usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-158
Product ID 27241-158_f537ddb1-f868-4bef-937b-e520b04e26a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212234
Listing Expiration 2027-12-31
Marketing Start 2019-12-26

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 27241158
Hyphenated Format 27241-158

Supplemental Identifiers

RxCUI
313566
UPC
0327241158605
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 ANDA212234 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (27241-158-60)
source: ndc

Packages (1)

27241-158-60 60 TABLET in 1 BOTTLE (27241-158-60)

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": "f537ddb1-f868-4bef-937b-e520b04e26a0", "openfda": {"upc": ["0327241158605"], "unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["d13cc8ad-eaf0-4ae6-89da-a850a08b1067"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (27241-158-60)", "package_ndc": "27241-158-60", "marketing_start_date": "20191226"}], "brand_name": "Valganciclovir", "product_id": "27241-158_f537ddb1-f868-4bef-937b-e520b04e26a0", "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": "27241-158", "generic_name": "Valganciclovir", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA212234", "marketing_category": "ANDA", "marketing_start_date": "20191226", "listing_expiration_date": "20271231"}