Lamotrigine

Lamotrigine Extended Release Rx Only These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. Initial U.S. Approval: 1994

Approved

Approval ID

a63e19c0-a093-e896-e053-2a95a90a7ccd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers

FDA

AvKARE

DUNS: 796560394

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lamotrigine

PRODUCT DETAILS

NDC Product Code42291-447

Application NumberANDA207497

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJanuary 9, 2024

Generic NameLamotrigine

INGREDIENTS (13)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

LAMOTRIGINEActive

Quantity: 250 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

Lamotrigine

PRODUCT DETAILS

NDC Product Code42291-444

Application NumberANDA207497

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJanuary 9, 2024

Generic NameLamotrigine

INGREDIENTS (13)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LAMOTRIGINEActive

Quantity: 50 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

Lamotrigine

PRODUCT DETAILS

NDC Product Code42291-446

Application NumberANDA207497

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJanuary 9, 2024

Generic NameLamotrigine

INGREDIENTS (12)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

LAMOTRIGINEActive

Quantity: 200 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

Lamotrigine

PRODUCT DETAILS

NDC Product Code42291-443

Application NumberANDA207497

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJanuary 9, 2024

Generic NameLamotrigine

INGREDIENTS (13)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

LAMOTRIGINEActive

Quantity: 25 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

Lamotrigine

PRODUCT DETAILS

NDC Product Code42291-448

Application NumberANDA207497

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJanuary 9, 2024

Generic NameLamotrigine

INGREDIENTS (12)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

LAMOTRIGINEActive

Quantity: 300 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

Lamotrigine

PRODUCT DETAILS

NDC Product Code42291-445

Application NumberANDA207497

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJanuary 9, 2024

Generic NameLamotrigine

INGREDIENTS (13)

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LAMOTRIGINEActive

Quantity: 100 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

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Lamotrigine

Products 6

Lamotrigine

PRODUCT DETAILS

INGREDIENTS (13)

Lamotrigine

PRODUCT DETAILS

INGREDIENTS (13)

Lamotrigine

PRODUCT DETAILS

INGREDIENTS (12)

Lamotrigine

PRODUCT DETAILS

INGREDIENTS (13)

Lamotrigine

PRODUCT DETAILS

INGREDIENTS (12)

Lamotrigine

PRODUCT DETAILS

INGREDIENTS (13)

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