valganciclovir

Generic: valganciclovir

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

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 450 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-762
Product ID 55111-762_01a187d9-f0b8-d068-0be0-98654e8de135
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203511
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

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 55111762
Hyphenated Format 55111-762

Supplemental Identifiers

RxCUI
313566
UPC
0355111762607
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 ANDA203511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-762-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (55111-762-60)
  • 10 BLISTER PACK in 1 CARTON (55111-762-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-762-79)
source: ndc

Packages (3)

55111-762-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-762-05) 55111-762-60 60 TABLET, FILM COATED in 1 BOTTLE (55111-762-60) 55111-762-78 10 BLISTER PACK in 1 CARTON (55111-762-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-762-79)

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": "01a187d9-f0b8-d068-0be0-98654e8de135", "openfda": {"upc": ["0355111762607"], "unii": ["4P3T9QF9NZ"], "rxcui": ["313566"], "spl_set_id": ["f37c0780-b953-46c2-d7d4-959fc2c3e571"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-762-05)", "package_ndc": "55111-762-05", "marketing_start_date": "20141215"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (55111-762-60)", "package_ndc": "55111-762-60", "marketing_start_date": "20141215"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-762-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-762-79)", "package_ndc": "55111-762-78", "marketing_start_date": "20141215"}], "brand_name": "Valganciclovir", "product_id": "55111-762_01a187d9-f0b8-d068-0be0-98654e8de135", "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": "55111-762", "generic_name": "Valganciclovir", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "450 mg/1"}], "application_number": "ANDA203511", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}