FDA.reportPublic FDA data

GANCICLOVIR

Product NDC
51754-2500
11-digit product format
517542500
Labeler code
51754
Product ID
51754-2500_238a983f-81bb-4033-b6ca-5fee7d6d291c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GANCICLOVIR
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
EXELA PHARMA SCIENCES, LLC
Application
NDA209347
Marketing category
NDA
Marketing start
2017-02-28
Marketing end
0000-00-00
Substance
GANCICLOVIR
Active strength
2 mg/mL
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86Product name920221206
9f9c8b60-edb9-4f29-9472-12fa266e8eadProduct name520190912
db601a58-ade5-4a08-a9d0-73d4222e8e5aProduct name120170505
af7ea8c4-c902-5a51-fdbc-62597b8c28f9Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51754-2500-12026-01-29C16284748780-149896155-b99d-586f-e063-e6dba90add90These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR INJECTION, for intravenous use Initial U.S. Approval: 1989
51754-2500-32026-01-29C16284748780-149896155-b99d-586f-e063-e6dba90add90These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR INJECTION, for intravenous use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51754-2500-1GANCICLOVIR250 mL in 1 BAGINJECTION, SOLUTION2503
51754-2500-3GANCICLOVIR250 mL in 1 BAGINJECTION, SOLUTION2503
51754-2500-3GANCICLOVIR10 in 1 POUCHINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-2500-1ML - Milliliter51754-250046998e8e-d9b1-41b5-944e-8e26b94c75e312017-06-15
51754-2500-3ML - Milliliter51754-250017b2495e-cecd-47cc-8652-0dee598dc69712017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-2500GANCICLOVIR INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]3Legacy NDC, 3 package rows20171006_26361de8-39b5-4266-90f6-2b307940135d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872065ganciclovir 500 MG in 250 mL InjectionPSN26361de8-39b5-4266-90f6-2b307940135d3
1872065250 ML ganciclovir 2 MG/ML InjectionSCD26361de8-39b5-4266-90f6-2b307940135d3
1872065ganciclovir 500 MG per 250 ML InjectionSY26361de8-39b5-4266-90f6-2b307940135d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-2500-151754250001250 mL in 1 BAG (51754-2500-1) 250 ml2017-02-280000-00-00NoNoCurrent
51754-2500-35175425000310 BAG in 1 POUCH (51754-2500-3) > 250 mL in 1 BAG10 bag2017-02-280000-00-00NoNoCurrent