MedPath

MEMANTINE HYDROCHLORIDE

Memantine HCL

Approved
Approval ID

d0839a2d-35f1-1f14-e053-2995a90ad549

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 11, 2021

Manufacturers
FDA

DirectRx

DUNS: 079254320

Products 1

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

MEMANTINE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code72189-294
Application NumberANDA090961
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 11, 2021
Generic NameMEMANTINE HYDROCHLORIDE

INGREDIENTS (11)

MEMANTINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
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MEMANTINE HYDROCHLORIDE - FDA Approval | MedPath