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 Capsule, for oral use Initial U.S. Approval: 2003

Approved

Approval ID

f6ce7cca-d245-44f2-986c-2a8d85dbb5fb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 21, 2019

Manufacturers

FDA

Major Pharmaceuticals

DUNS: 191427277

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 Code0904-6735

Application NumberANDA206028

Product Classification

Marketing Category

C73584

Generic Name

memantine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJune 21, 2019

FDA Product Classification

INGREDIENTS (15)

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

MEMANTINE HYDROCHLORIDEActive

Quantity: 28 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

memantine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0904-6736

Application NumberANDA206028

Product Classification

Marketing Category

C73584

Generic Name

memantine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJune 21, 2019

FDA Product Classification

INGREDIENTS (17)

MEMANTINE HYDROCHLORIDEActive

Quantity: 14 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

memantine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0904-6734

Application NumberANDA206028

Product Classification

Marketing Category

C73584

Generic Name

memantine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJune 21, 2019

FDA Product Classification

INGREDIENTS (15)

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

MEMANTINE HYDROCHLORIDEActive

Quantity: 7 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

memantine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0904-6737

Application NumberANDA206028

Product Classification

Marketing Category

C73584

Generic Name

memantine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJune 21, 2019

FDA Product Classification

INGREDIENTS (15)

MEMANTINE HYDROCHLORIDEActive

Quantity: 21 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

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memantine hydrochloride

Products 4

memantine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

memantine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

memantine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

memantine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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