FDA.reportPublic FDA data

Ganciclovir

Product NDC
51817-171
11-digit product format
518170171
Labeler code
51817
Product ID
51817-171_f05916fd-4785-f545-e053-2995a90aa901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ganciclovir sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmascience Inc.
Application
ANDA207645
Marketing category
ANDA
Marketing start
2018-04-24
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
Rxcui1999531

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
51817-171-01Ganciclovir25 in 1 CARTONINJECTION, SOLUTION259
51817-171-01Ganciclovir10 mL in 1 VIALINJECTION, SOLUTION109
51817-171-02Ganciclovir1 in 1 CARTONINJECTION, SOLUTION19
51817-171-02Ganciclovir10 mL in 1 VIALINJECTION, SOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51817-171GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, SOLUTION [PHARMASCIENCE INC.]9Current NDC, Legacy NDC, 4 package rows20221223_3059c2da-d4a7-4aea-828c-20e671cb875c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999531ganciclovir 500 MG in 10 ML InjectionPSN3059c2da-d4a7-4aea-828c-20e671cb875c9
199953110 ML ganciclovir 50 MG/ML InjectionSCD3059c2da-d4a7-4aea-828c-20e671cb875c9
1999531ganciclovir 500 MG per 10 ML InjectionSY3059c2da-d4a7-4aea-828c-20e671cb875c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51817-171-015181701710125 VIAL in 1 CARTON (51817-171-01) / 10 mL in 1 VIAL25 vial2018-04-240000-00-00NoNoCurrent
51817-171-02518170171021 VIAL in 1 CARTON (51817-171-02) / 10 mL in 1 VIAL1 vial2019-12-150000-00-00NoNoCurrent