Memantine Hydrochloride

These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2003

Approved

Approval ID

f2b7538d-8ca1-4ac7-a172-d268e2fa9a52

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 10, 2023

Manufacturers

FDA

Amneal Pharmaceuticals LLC

DUNS: 123797875

Products 4

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

Memantine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-783

Application NumberANDA205825

Product Classification

Marketing Category

C73584

Generic Name

Memantine Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (19)

MEMANTINE HYDROCHLORIDEActive

Quantity: 14 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

Memantine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-785

Application NumberANDA205825

Product Classification

Marketing Category

C73584

Generic Name

Memantine Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (19)

MEMANTINE HYDROCHLORIDEActive

Quantity: 28 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Memantine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-784

Application NumberANDA205825

Product Classification

Marketing Category

C73584

Generic Name

Memantine Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (19)

GELATINInactive

Code: 2G86QN327L

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

MEMANTINE HYDROCHLORIDEActive

Quantity: 21 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Memantine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-782

Application NumberANDA205825

Product Classification

Marketing Category

C73584

Generic Name

Memantine Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (19)

MEMANTINE HYDROCHLORIDEActive

Quantity: 7 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

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Memantine Hydrochloride

Products 4

Memantine Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Memantine Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Memantine Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Memantine Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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