FDA.reportPublic FDA data

Ganciclovir

Product NDC
63323-315
11-digit product format
633230315
Labeler code
63323
Product ID
63323-315_41a1504e-f02c-4ec1-9650-709e945234eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GANCICLOVIR SODIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA090658
Marketing category
ANDA
Marketing start
2010-06-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ganciclovir
Listing expiration
2027-12-31

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
63323-315-01Ganciclovir10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,108
63323-315-10Ganciclovir25 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,258
63323-315-41Ganciclovir10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,106
63323-315-94Ganciclovir25 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-315-01EA - Each63323-315d929a64e-56ff-468a-b612-d64bad52c61d12024-08-12
63323-315-10EA - Each63323-31597237f6c-e784-4c86-9717-4105ccc30cd912012-07-24
63323-315-94EA - Each63323-3155d552e4f-dcb0-4446-a667-e71f5006bbd712014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GANCICLOVIR SODIUMACTIVE INGREDIENT02L083W284GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
GANCICLOVIRACTIVE MOIETYP9G3CKZ4P5GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
GANCICLOVIR SODIUMACTIVE INGREDIENT02L083W284GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
GANCICLOVIRACTIVE MOIETYP9G3CKZ4P5GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-315GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20221203_b47f5d1c-36b8-49b6-a410-3b3f4661dde7.zip
63323-315GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, Legacy NDC, 2 package rows20230115_35addab5-09db-4f8a-9c69-6fbce33ecc37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310442ganciclovir 500 MG InjectionPSNb47f5d1c-36b8-49b6-a410-3b3f4661dde78
310442ganciclovir 500 MG InjectionSCDb47f5d1c-36b8-49b6-a410-3b3f4661dde78
310442ganciclovir 500 MG (as ganciclovir sodium) InjectionSYb47f5d1c-36b8-49b6-a410-3b3f4661dde78
310442ganciclovir 500 MG InjectionPSN35addab5-09db-4f8a-9c69-6fbce33ecc376
310442ganciclovir 500 MG InjectionSCD35addab5-09db-4f8a-9c69-6fbce33ecc376
310442ganciclovir 500 MG (as ganciclovir sodium) InjectionSY35addab5-09db-4f8a-9c69-6fbce33ecc376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-315-016332303150110 mL in 1 VIAL10 mlHistorical
63323-315-106332303151025 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01) 25 vial2010-06-280000-00-00NoNoCurrent
63323-315-416332303154110 mL in 1 VIAL10 mlHistorical
63323-315-946332303159425 VIAL in 1 TRAY (63323-315-94) / 10 mL in 1 VIAL (63323-315-41) 25 vial2010-06-280000-00-00NoNoCurrent