BARACLUDE
These highlights do not include all the information needed to use BARACLUDE safely and effectively. See full prescribing information for BARACLUDE. BARACLUDE (entecavir) tablets, for oral useBARACLUDE (entecavir) oral solutionInitial U.S. Approval: 2005
Approved
Approval ID
046e61c9-9298-4b2e-b76e-b26b81fecd20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2023
Manufacturers
FDA
E.R. Squibb & Sons, L.L.C.
DUNS: 011550092
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
entecavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-1614
Application NumberNDA021798
Product Classification
M
Marketing Category
C73594
G
Generic Name
entecavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2018
FDA Product Classification
INGREDIENTS (6)
ENTECAVIRActive
Quantity: 0.05 mg in 1 mL
Code: 5968Y6H45M
Classification: ACTIB
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
entecavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-1612
Application NumberNDA021797
Product Classification
M
Marketing Category
C73594
G
Generic Name
entecavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2018
FDA Product Classification
INGREDIENTS (10)
ENTECAVIRActive
Quantity: 1.0 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
entecavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-1611
Application NumberNDA021797
Product Classification
M
Marketing Category
C73594
G
Generic Name
entecavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2018
FDA Product Classification
INGREDIENTS (10)
ENTECAVIRActive
Quantity: 0.5 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT