lamotrigine

LAMOTRIGINE extended-release tablets Yiling pharmaceutical Ltd ------------------------------------------------------------- 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. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994

Approved

Approval ID

f7de11a5-5357-4753-b1ac-b15123b50028

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 22, 2022

Manufacturers

FDA

Yiling Pharmaceutical, Inc.

DUNS: 079417422

Products 6

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

lamotrigine extended-release

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69117-0049

Application NumberANDA213949

Product Classification

Marketing Category

C73584

Generic Name

lamotrigine extended-release

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 22, 2022

FDA Product Classification

INGREDIENTS (14)

LAMOTRIGINEActive

Quantity: 300 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

GLYCERYL MONO AND DIPALMITOSTEARATEInactive

Code: KC98RO82HJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

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

Code: NX76LV5T8J

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

lamotrigine extended-release

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69117-0044

Application NumberANDA213949

Product Classification

Marketing Category

C73584

Generic Name

lamotrigine extended-release

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 22, 2022

FDA Product Classification

INGREDIENTS (16)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

GLYCERYL MONO AND DIPALMITOSTEARATEInactive

Code: KC98RO82HJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

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

Code: NX76LV5T8J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

LAMOTRIGINEActive

Quantity: 25 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

lamotrigine extended-release

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69117-0047

Application NumberANDA213949

Product Classification

Marketing Category

C73584

Generic Name

lamotrigine extended-release

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 22, 2022

FDA Product Classification

INGREDIENTS (15)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

GLYCERYL MONO AND DIPALMITOSTEARATEInactive

Code: KC98RO82HJ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

LAMOTRIGINEActive

Quantity: 200 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

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

Code: NX76LV5T8J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

lamotrigine extended-release

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69117-0048

Application NumberANDA213949

Product Classification

Marketing Category

C73584

Generic Name

lamotrigine extended-release

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 22, 2022

FDA Product Classification

INGREDIENTS (16)

GLYCERYL MONO AND DIPALMITOSTEARATEInactive

Code: KC98RO82HJ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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

Code: NX76LV5T8J

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

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 REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

LAMOTRIGINEActive

Quantity: 250 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

lamotrigine extended-release

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69117-0046

Application NumberANDA213949

Product Classification

Marketing Category

C73584

Generic Name

lamotrigine extended-release

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 22, 2022

FDA Product Classification

INGREDIENTS (16)

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GLYCERYL MONO AND DIPALMITOSTEARATEInactive

Code: KC98RO82HJ

Classification: IACT

LAMOTRIGINEActive

Quantity: 100 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

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

Code: NX76LV5T8J

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

lamotrigine extended-release

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69117-0045

Application NumberANDA213949

Product Classification

Marketing Category

C73584

Generic Name

lamotrigine extended-release

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 22, 2022

FDA Product Classification

INGREDIENTS (16)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

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

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

LAMOTRIGINEActive

Quantity: 50 mg in 1 1

Code: U3H27498KS

Classification: ACTIB

GLYCERYL MONO AND DIPALMITOSTEARATEInactive

Code: KC98RO82HJ

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

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lamotrigine

Products 6

lamotrigine extended-release

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

lamotrigine extended-release

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

lamotrigine extended-release

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

lamotrigine extended-release

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

lamotrigine extended-release

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

lamotrigine extended-release

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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