ganciclovir

Generic: ganciclovir

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganciclovir
Generic Name ganciclovir
Labeler endo usa, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ganciclovir sodium 500 mg/10mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 42023-173
Product ID 42023-173_f04cdda8-4829-4fa1-8cf2-503479c89b1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204950
Listing Expiration 2026-12-31
Marketing Start 2016-12-06

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 42023173
Hyphenated Format 42023-173

Supplemental Identifiers

RxCUI
310442
UNII
02L083W284

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 ganciclovir (source: ndc)
Generic Name ganciclovir (source: ndc)
Application Number ANDA204950 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)
source: ndc

Packages (1)

42023-173-25 25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)

Ingredients (1)

ganciclovir sodium (500 mg/10mL)

Linked Drug Pages (1)

Ganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f04cdda8-4829-4fa1-8cf2-503479c89b1e", "openfda": {"unii": ["02L083W284"], "rxcui": ["310442"], "spl_set_id": ["87afd103-6e64-444f-971d-0e732e9ae995"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25)  / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)", "package_ndc": "42023-173-25", "marketing_start_date": "20161206"}], "brand_name": "Ganciclovir", "product_id": "42023-173_f04cdda8-4829-4fa1-8cf2-503479c89b1e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "42023-173", "generic_name": "Ganciclovir", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganciclovir", "active_ingredients": [{"name": "GANCICLOVIR SODIUM", "strength": "500 mg/10mL"}], "application_number": "ANDA204950", "marketing_category": "ANDA", "marketing_start_date": "20161206", "listing_expiration_date": "20261231"}