Eslicarbazepine Acetate
These highlights do not include all the information needed to use ESLICARBAZEPINE ACETATE TABLETS safely and effectively. See full prescribing information for ESLICARBAZEPINE ACETATE TABLETS. ESLICARBAZEPINE ACETATE tablets, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
999b341f-fe13-4dd9-bb95-9b0d6a817c4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2025
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Eslicarbazepine Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-291
Application NumberANDA211246
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eslicarbazepine Acetate
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2025
FDA Product Classification
INGREDIENTS (7)
ESLICARBAZEPINE ACETATEActive
Quantity: 400 mg in 1 1
Code: BEA68ZVB2K
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Eslicarbazepine Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-290
Application NumberANDA211246
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eslicarbazepine Acetate
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2025
FDA Product Classification
INGREDIENTS (7)
ESLICARBAZEPINE ACETATEActive
Quantity: 200 mg in 1 1
Code: BEA68ZVB2K
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Eslicarbazepine Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-293
Application NumberANDA211246
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eslicarbazepine Acetate
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2025
FDA Product Classification
INGREDIENTS (7)
ESLICARBAZEPINE ACETATEActive
Quantity: 800 mg in 1 1
Code: BEA68ZVB2K
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Eslicarbazepine Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-292
Application NumberANDA211246
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eslicarbazepine Acetate
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2025
FDA Product Classification
INGREDIENTS (7)
ESLICARBAZEPINE ACETATEActive
Quantity: 600 mg in 1 1
Code: BEA68ZVB2K
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT