FDA.reportPublic FDA data

NDC 42023-173-01 - Ganciclovir

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
42023-173
Requested NDC
42023-173-01
Package NDCs from labels
42023-173-01, 42023-173-25
Manufacturer
Par Health USA, LLC
Effective date
2026-09-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ganciclovir - Par Health USA, LLCPar Health USA, LLC2026-09-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-173-01Ganciclovir10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,107
42023-173-25Ganciclovir25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-173GANCICLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]7Current NDC, Legacy NDC, 2 package rows20241114_87afd103-6e64-444f-971d-0e732e9ae995.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-173-01EA - Each42023-1738ed1ce31-c975-4e0d-ac0b-03e3fd359d8c12017-05-03
42023-173-25EA - Each42023-173958a7e80-41eb-4b06-b208-7de784dfa19312017-05-03

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GanciclovirGANCICLOVIR SODIUMFresenius Kabi USA, LLCb47f5d1c-36b8-49b6-a410-3b3f4661dde72026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310442
unii: 02L083W284
GanciclovirGANCICLOVIR SODIUMFresenius Kabi USA, LLC35addab5-09db-4f8a-9c69-6fbce33ecc372026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310442
unii: 02L083W284
GanciclovirGANCICLOVIR SODIUMHikma Pharmaceuticals USA Inc.4f8219ca-6780-4131-8962-9c3fdd0a84dd2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310442
unii: 02L083W284
ganciclovirGANCICLOVIR SODIUMSlate Run Pharmaceuticals, LLCeb100366-2a64-4742-af11-6177a8a494c82025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310442
unii: 02L083W284
ganciclovir sodiumGANCICLOVIR SODIUMSlate Run Pharmaceuticals, LLCcd293b9d-b573-4656-8574-19d7db870a9b2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310442
unii: 02L083W284
GanciclovirGANCICLOVIR SODIUMPharmascience Inc.3059c2da-d4a7-4aea-828c-20e671cb875c2022-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 02L083W284
f04cdda8-4829-4fa1-8cf2-503479c89b1e87afd103-6e64-444f-971d-0e732e9ae9952020-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: f04cdda8-4829-4fa1-8cf2-503479c89b1e
spl set id: 87afd103-6e64-444f-971d-0e732e9ae995
ganciclovirGANCICLOVIR SODIUMSagent Pharmaceuticals993151ed-cea7-49a7-a967-fac3e9b3c85f2020-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 02L083W284

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.