FDA.reportPublic FDA data

Ganciclovir

Product NDC
0143-9299
11-digit product format
001439299
Labeler code
0143
Product ID
0143-9299_192fd7cc-3a38-4afe-82f3-a4d89238b1ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ganciclovir sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076222
Marketing category
ANDA
Marketing start
2021-06-17
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
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
0143-9299-01Ganciclovir10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,107
0143-9299-10Ganciclovir10 in 1 BOXINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9299-01EA - Each0143-92995667cd7e-dd77-47ce-b7ec-5e288ba2a31e12021-07-15
0143-9299-10EA - Each0143-929903db0a2b-7d73-4138-b231-9db45651e2d112021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9299GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250210_4f8219ca-6780-4131-8962-9c3fdd0a84dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310442ganciclovir 500 MG InjectionPSN4f8219ca-6780-4131-8962-9c3fdd0a84dd7
310442ganciclovir 500 MG InjectionSCD4f8219ca-6780-4131-8962-9c3fdd0a84dd7
310442ganciclovir 500 MG (as ganciclovir sodium) InjectionSY4f8219ca-6780-4131-8962-9c3fdd0a84dd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9299-010014392990110 mL in 1 VIAL10 mlHistorical
0143-9299-100014392991010 VIAL in 1 BOX (0143-9299-10) / 10 mL in 1 VIAL (0143-9299-01) 10 vial2021-06-170000-00-00NoNoCurrent