valganciclovir hydrochloride

Generic: valganciclovir hydrochloride

Labeler: dr. reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir hydrochloride
Generic Name valganciclovir hydrochloride
Labeler dr. reddy's laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-356
Product ID 43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206876
Listing Expiration 2026-12-31
Marketing Start 2017-12-12

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 43598356
Hyphenated Format 43598-356

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 ANDA206876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43598-356-30)
  • 60 TABLET in 1 BOTTLE (43598-356-60)
source: ndc

Packages (2)

43598-356-30 30 TABLET in 1 BOTTLE (43598-356-30) 43598-356-60 60 TABLET in 1 BOTTLE (43598-356-60)

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": "2fbdd00d-733b-49f9-70b4-c1aefa75d6a4", "openfda": {"unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["e30ae2b2-dad2-39ba-6bc7-400807791ab0"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43598-356-30)", "package_ndc": "43598-356-30", "marketing_start_date": "20171212"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43598-356-60)", "package_ndc": "43598-356-60", "marketing_start_date": "20171212"}], "brand_name": "valganciclovir hydrochloride", "product_id": "43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4", "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": "43598-356", "generic_name": "valganciclovir hydrochloride", "labeler_name": "Dr. Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "valganciclovir hydrochloride", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA206876", "marketing_category": "ANDA", "marketing_start_date": "20171212", "listing_expiration_date": "20261231"}