FDA.reportPublic FDA data

ganciclovir sodium

Product NDC
70436-231
11-digit product format
704360231
Labeler code
70436
Product ID
70436-231_2ac6c72f-6f19-825c-e063-6294a90af661
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ganciclovir sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA204204
Marketing category
ANDA
Marketing start
2019-01-01
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 sodium
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
70436-231-55ganciclovir sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,102
70436-231-55ganciclovir sodium25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-231-55EA - Each70436-231bb1fbc66-19f8-4c4f-899a-87145c3c048512025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-231GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20250104_cd293b9d-b573-4656-8574-19d7db870a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310442ganciclovir 500 MG InjectionPSNcd293b9d-b573-4656-8574-19d7db870a9b2
310442ganciclovir 500 MG InjectionSCDcd293b9d-b573-4656-8574-19d7db870a9b2
310442ganciclovir 500 MG (as ganciclovir sodium) InjectionSYcd293b9d-b573-4656-8574-19d7db870a9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-231-557043602315525 VIAL in 1 CARTON (70436-231-55) / 10 mL in 1 VIAL25 vial2024-09-01NoNoCurrent