GANCICLOVIR
GANCICLOVIR CAPSULESRx onlyFOR ORAL ADMINISTRATION
Approved
Approval ID
3406db8a-5ae9-4120-94bd-036701adbeca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2011
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GANCICLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-636
Application NumberANDA076457
Product Classification
M
Marketing Category
C73584
G
Generic Name
GANCICLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2011
FDA Product Classification
INGREDIENTS (12)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GANCICLOVIRActive
Quantity: 250 mg in 1 1
Code: P9G3CKZ4P5
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GANCICLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-637
Application NumberANDA076457
Product Classification
M
Marketing Category
C73584
G
Generic Name
GANCICLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2011
FDA Product Classification
INGREDIENTS (12)
GANCICLOVIRActive
Quantity: 500 mg in 1 1
Code: P9G3CKZ4P5
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT