Namenda

Product NDC: 0456-3205
11-digit product format: 004563205
Labeler code: 0456
Product ID: 0456-3205_d2d531d0-0380-4b22-90e8-ca93627b7900
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA021487
Marketing category: NDA
Marketing start: 2003-10-16
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0456-3205		D	Discontinued by firm	2026-07-31
excluded package	package	0456-3205	0456-3205-60	D	Discontinued by firm	2026-07-31
excluded package	package	0456-3205	0456-3205-63	D	Discontinued by firm	2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021487-001	NAMENDA	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		RLD	2003-10-16
N021487-002	NAMENDA	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		RLD	2003-10-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021487-001	NAMENDA	5MG	TABLET / ORAL		RLD	2003-10-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021487-002	NAMENDA	10MG	TABLET / ORAL		RLD	2003-10-16	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	e5754973-e73b-4a25-abb4-80f91880f018	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Actavis Pharma, Inc.	72973b46-f307-4a9e-8fb1-ad2cbccfd736	2018-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c8f5c20b-4573-44c5-89fc-4da11b2e1fe1	2017-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94db636e-a074-45fd-8e8d-331920a99436	Product name	4	20250103
941773f8-a40e-0684-da08-ff9a143e6368	Product name	7	20231219
5b597f00-4538-4686-aa4e-3c60ed3788c8	Product name	2	20210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2	Product name	9	20151209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0456-3205-11	EA - Each	0456-3205	6e72b62b-568b-4feb-8871-c704eedd2c88	1	2013-02-13
0456-3205-60	EA - Each	0456-3205	29f0a396-ef25-47cb-a7b5-f6e7be5dc2a9	1	2012-07-24
0456-3205-63	EA - Each	0456-3205	4a7bb2c2-6b85-43d1-9867-e474f09fc683	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEMANTINE HYDROCHLORIDE	ACTIVE INGREDIENT	JY0WD0UA60	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
MEMANTINE	ACTIVE MOIETY	W8O17SJF3T	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
MEMANTINE HYDROCHLORIDE	ACTIVE INGREDIENT	JY0WD0UA60	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
memantine	ACTIVE MOIETY	W8O17SJF3T	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
FD&C blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
sorbitol	INACTIVE INGREDIENT	506T60A25R	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
talc	INACTIVE INGREDIENT	7SEV7J4R1U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]	8
Memantine Hydrochloride	ACTIVE INGREDIENT	JY0WD0UA60	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
Memantine	ACTIVE MOIETY	W8O17SJF3T	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	2
MEMANTINE HYDROCHLORIDE	ACTIVE INGREDIENT	JY0WD0UA60	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
MEMANTINE	ACTIVE MOIETY	W8O17SJF3T	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0456-3205	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [ALLERGAN, INC.]	19	Legacy NDC	20241220_b9f27baf-aa2a-443a-9ef5-e002d23407ba.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996561	memantine HCl 10 MG Oral Tablet	PSN	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996571	memantine HCl 5 MG Oral Tablet	PSN	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996563	Namenda 10 MG Oral Tablet	PSN	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996574	Namenda 5 MG Oral Tablet	PSN	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996563	memantine hydrochloride 10 MG Oral Tablet [Namenda]	SBD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996574	memantine hydrochloride 5 MG Oral Tablet [Namenda]	SBD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996563	Namenda 10 MG Oral Tablet	SY	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996574	Namenda 5 MG Oral Tablet	SY	74ce605d-b493-4b95-9d59-9253f81f4e20	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0456-3205-60	00456320560	60 TABLET in 1 BOTTLE (0456-3205-60)	60 tablet	2003-10-16	0000-00-00	No	No	Current
0456-3205-63	00456320563	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-3205-63) > 10 TABLET in 1 BLISTER PACK (0456-3205-11)	10 blister pack	2003-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Namenda	Bryant Ranch Prepack	2019-09-12	HUMAN PRESCRIPTION DRUG LABEL	1002
Namenda	Cardinal Health	2019-04-02	HUMAN PRESCRIPTION DRUG LABEL	4
Namenda	Allergan, Inc.	2018-11-01	HUMAN PRESCRIPTION DRUG LABEL	19
Namenda	Rebel Distributors Corp	2010-12-29	HUMAN PRESCRIPTION DRUG LABEL	1