FDA.reportPublic FDA data

ganciclovir

Product NDC
25021-185
11-digit product format
250210185
Labeler code
25021
Product ID
25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ganciclovir sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207645
Marketing category
ANDA
Marketing start
2018-02-15
Substance
GANCICLOVIR SODIUM
Active strength
50 mg/mL
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 SODIUM50 mg/mL

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
25021-185-10ganciclovir25 in 1 CARTONINJECTION, SOLUTION255
25021-185-10ganciclovir10 mL in 1 VIALINJECTION, SOLUTION105
25021-185-11ganciclovir10 mL in 1 VIALINJECTION, SOLUTION105
25021-185-11ganciclovir1 in 1 CARTONINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-185-10ML - Milliliter25021-185cb035396-63f8-4dea-b5eb-72960ab6f98a12018-05-09
25021-185-11ML - Milliliter25021-185aa94291a-0b2d-4b83-91f7-ff07ec67ef7a12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-185GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20221201_993151ed-cea7-49a7-a967-fac3e9b3c85f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999531ganciclovir 500 MG in 10 ML InjectionPSN993151ed-cea7-49a7-a967-fac3e9b3c85f5
199953110 ML ganciclovir 50 MG/ML InjectionSCD993151ed-cea7-49a7-a967-fac3e9b3c85f5
1999531ganciclovir 500 MG per 10 ML InjectionSY993151ed-cea7-49a7-a967-fac3e9b3c85f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-185-102502101851025 VIAL in 1 CARTON (25021-185-10) / 10 mL in 1 VIAL25 vial2018-02-150000-00-00NoNoCurrent
25021-185-11250210185111 VIAL in 1 CARTON (25021-185-11) > 10 mL in 1 VIAL1 vial2019-12-152023-09-30NoNoCurrent