Generic Drug
Approved
Approval ID
802cbfd0-0dbe-638f-e053-2991aa0a6841
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2019
Manufacturers
FDA
Ningbo Shouzheng Medicinal Research Co., Ltd
DUNS: 544579913
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Memantine Hydrochloride Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72994-002
Product Classification
G
Generic Name
Memantine Hydrochloride Tablets
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2019
FDA Product Classification
INGREDIENTS (8)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Memantine Hydrochloride Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72994-001
Product Classification
G
Generic Name
Memantine Hydrochloride Tablets
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2019
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT