FDA.reportPublic FDA data

Ganciclovir

Product NDC
14335-030
11-digit product format
143350030
Labeler code
14335
Product ID
14335-030_80b86c46-230e-0090-e053-2991aa0a8fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ganciclovir sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENTRICULAR
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA204204
Marketing category
ANDA
Marketing start
2019-02-11
Marketing end
0000-00-00
Substance
GANCICLOVIR SODIUM
Active strength
50 mg/mL
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14335-030-012022-01-28C16284748780-1d6a99b39-4fd8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. GANCICLOVIR for Injection, USP for intravenous use Initial U.S. Approval: 1989
14335-030-252022-01-28C16284748780-1d6a99b39-4fd8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. GANCICLOVIR for Injection, USP for intravenous use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14335-030-01Ganciclovir10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,102
14335-030-01Ganciclovir10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102
14335-030-25Ganciclovir25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,252
14335-030-25Ganciclovir10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-030GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAINAN POLY PHARM. CO., LTD.]2Legacy NDC, 4 package rows20190211_69017374-ac20-4b8c-86c7-d35907046dce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310442ganciclovir 500 MG InjectionPSN69017374-ac20-4b8c-86c7-d35907046dce2
310442ganciclovir 500 MG InjectionSCD69017374-ac20-4b8c-86c7-d35907046dce2
310442ganciclovir 500 MG (as ganciclovir sodium) InjectionSY69017374-ac20-4b8c-86c7-d35907046dce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14335-030-011433500300110 VIAL in 1 CARTON (14335-030-01) > 10 mL in 1 VIAL10 vial2019-02-110000-00-00NoNoCurrent
14335-030-251433500302525 VIAL in 1 CARTON (14335-030-25) > 10 mL in 1 VIAL25 vial2019-02-110000-00-00NoNoCurrent