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FDA Approval

Eslicarbazepine Acetate

CompanyLupin Pharmaceuticals, Inc. (DUNS: 089153071)

Effective Date

April 3, 2025

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Eslicarbazepine acetate(400 mg in 1 1)

Registrants (1)

DUNS Number

675923163

Manufacturing Establishments (1)

Labeler

Lupin Pharmaceuticals, Inc.

Registrant

LUPIN LIMITED

DUNS Number

677600414

Products (4)

Eslicarbazepine Acetate

NDC Product Code

68180-291

Application Number

ANDA211246

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 3, 2025

Ingredients

Eslicarbazepine acetateActive

Code: BEA68ZVB2KClass: ACTIBQuantity: 400 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Eslicarbazepine Acetate

NDC Product Code

68180-290

Application Number

ANDA211246

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 3, 2025

Ingredients

Eslicarbazepine acetateActive

Code: BEA68ZVB2KClass: ACTIBQuantity: 200 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Eslicarbazepine Acetate

NDC Product Code

68180-293

Application Number

ANDA211246

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 3, 2025

Ingredients

Eslicarbazepine acetateActive

Code: BEA68ZVB2KClass: ACTIBQuantity: 800 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Eslicarbazepine Acetate

NDC Product Code

68180-292

Application Number

ANDA211246

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 3, 2025

Ingredients

Eslicarbazepine acetateActive

Code: BEA68ZVB2KClass: ACTIBQuantity: 600 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

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