FDA.reportPublic FDA data

Ganciclovir

Product NDC
42023-173
11-digit product format
420230173
Labeler code
42023
Product ID
42023-173_f04cdda8-4829-4fa1-8cf2-503479c89b1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ganciclovir
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Endo USA, Inc.
Application
ANDA204950
Marketing category
ANDA
Marketing start
2016-12-06
Substance
GANCICLOVIR SODIUM
Active strength
500 mg/10mL
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ganciclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GANCICLOVIR SODIUM500 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02L083W284
Rxcui310442

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

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310442ganciclovir 500 MG InjectionPSN87afd103-6e64-444f-971d-0e732e9ae9957
310442ganciclovir 500 MG InjectionSCD87afd103-6e64-444f-971d-0e732e9ae9957
310442ganciclovir 500 MG (as ganciclovir sodium) InjectionSY87afd103-6e64-444f-971d-0e732e9ae9957

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-173-014202301730110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
42023-173-254202301732525 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01) 2016-12-060000-00-00NoNoCurrent