GANCICLOVIR

Product NDC
63304-637
11-digit product format
633040637
Labeler code
63304
Product ID
63304-637_3406db8a-5ae9-4120-94bd-036701adbeca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GANCICLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076457
Marketing category
ANDA
Marketing start
2003-08-27
Marketing end
0000-00-00
Substance
GANCICLOVIR
Active strength
500 mg/1
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-637-05GANCICLOVIR500 in 1 BOTTLECAPSULE5001
63304-637-28GANCICLOVIR180 in 1 BOTTLECAPSULE1801
63304-637-60GANCICLOVIR60 in 1 BOTTLECAPSULE601
63304-637-90GANCICLOVIR90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-637-28EA - Each63304-63764783516-1c72-4a60-9f23-fe7525f685b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GANCICLOVIRACTIVE INGREDIENTP9G3CKZ4P5GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
GANCICLOVIRACTIVE MOIETYP9G3CKZ4P5GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-637GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1Legacy NDC, 4 package rows20140710_3406db8a-5ae9-4120-94bd-036701adbeca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314007ganciclovir 250 MG Oral CapsulePSN3406db8a-5ae9-4120-94bd-036701adbeca1
200206ganciclovir 500 MG Oral CapsulePSN3406db8a-5ae9-4120-94bd-036701adbeca1
314007ganciclovir 250 MG Oral CapsuleSCD3406db8a-5ae9-4120-94bd-036701adbeca1
200206ganciclovir 500 MG Oral CapsuleSCD3406db8a-5ae9-4120-94bd-036701adbeca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-637-0563304063705500 in 1 BOTTLEHistorical
63304-637-2863304063728180 in 1 BOTTLEHistorical
63304-637-606330406376060 in 1 BOTTLEHistorical
63304-637-906330406379090 in 1 BOTTLEHistorical