valganciclovir

Generic: valganciclovir

Labeler: florida pharmaceutical products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir
Generic Name valganciclovir
Labeler florida pharmaceutical products, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir 50 mg/mL

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-210
Product ID 71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216317
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

Pharmacologic Class

Established (EPC)
cytomegalovirus nucleoside analog dna polymerase inhibitor [epc]
Mechanism of Action
dna polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921210
Hyphenated Format 71921-210

Supplemental Identifiers

RxCUI
863559
UNII
GCU97FKN3R
NUI
N0000175461 N0000020060 N0000175459

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 ANDA216317 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71921-210-12) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

71921-210-12 1 BOTTLE in 1 CARTON (71921-210-12) / 100 mL in 1 BOTTLE

Ingredients (1)

valganciclovir (50 mg/mL)

Linked Drug Pages (1)

Valganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cc6c4939-7908-439c-b1b8-6b52e826c7a5", "openfda": {"nui": ["N0000175461", "N0000020060", "N0000175459"], "unii": ["GCU97FKN3R"], "rxcui": ["863559"], "spl_set_id": ["cc6c4939-7908-439c-b1b8-6b52e826c7a5"], "pharm_class_epc": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71921-210-12)  / 100 mL in 1 BOTTLE", "package_ndc": "71921-210-12", "marketing_start_date": "20230701"}], "brand_name": "Valganciclovir", "product_id": "71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "71921-210", "generic_name": "Valganciclovir", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir", "active_ingredients": [{"name": "VALGANCICLOVIR", "strength": "50 mg/mL"}], "application_number": "ANDA216317", "marketing_category": "ANDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}