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 useInitial U.S. Approval: 2003

Approved

Approval ID

a282fbed-8304-458e-a0e9-5eaccc95339b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 19, 2025

Manufacturers

FDA

Rising Pharma Holdings, Inc.

DUNS: 116880195

Products 4

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

memantine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16571-852

Application NumberANDA206032

Product Classification

Marketing Category

C73584

Generic Name

memantine

Product Specifications

Route of AdministrationORAL

Effective DateApril 19, 2025

FDA Product Classification

INGREDIENTS (17)

MEMANTINE HYDROCHLORIDEActive

Quantity: 7 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

memantine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16571-854

Application NumberANDA206032

Product Classification

Marketing Category

C73584

Generic Name

memantine

Product Specifications

Route of AdministrationORAL

Effective DateApril 19, 2025

FDA Product Classification

INGREDIENTS (17)

MEMANTINE HYDROCHLORIDEActive

Quantity: 21 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

memantine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16571-855

Application NumberANDA206032

Product Classification

Marketing Category

C73584

Generic Name

memantine

Product Specifications

Route of AdministrationORAL

Effective DateApril 19, 2025

FDA Product Classification

INGREDIENTS (17)

MEMANTINE HYDROCHLORIDEActive

Quantity: 28 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

memantine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16571-853

Application NumberANDA206032

Product Classification

Marketing Category

C73584

Generic Name

memantine

Product Specifications

Route of AdministrationORAL

Effective DateApril 19, 2025

FDA Product Classification

INGREDIENTS (18)

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

MEMANTINE HYDROCHLORIDEActive

Quantity: 14 mg in 1 1

Code: JY0WD0UA60

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

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Memantine Hydrochloride

Products 4

memantine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

memantine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

memantine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

memantine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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