Namenda

Product NDC: 21695-169
11-digit product format: 216950169
Labeler code: 21695
Product ID: 21695-169_74ce605d-b493-4b95-9d59-9253f81f4e20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021487
Marketing category: NDA
Marketing start: 2004-11-17
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-169		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-169	21695-169-30	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-169	21695-169-60	I	Inactivated by FDA	2026-08-03

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.

Product history page 1 of 3 · 82 observed 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
2026-02-19 14:30 UTC	2026-02	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021487-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021487-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021487-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021487-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021487-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021487-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021487-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021487-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021487-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021487-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021487-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021487-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021487-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021487-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021487-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021487-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021487-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021487-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-169-30	2019-09-24	C162847	48780-1	934fe258-4cfe-48b1-e053-8cdaa90a720a	Namenda
21695-169-60	2019-09-24	C162847	48780-1	934fe258-4cfe-48b1-e053-8cdaa90a720a	Namenda

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-169-30	Namenda	30 in 1 BOTTLE	TABLET	30		1
21695-169-60	Namenda	60 in 1 BOTTLE	TABLET	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-169-30	EA - Each	21695-169	a92892f5-dfd1-44a8-ba0a-309ebfd3f897	1	2012-07-24
21695-169-60	EA - Each	21695-169	585c96de-7a3e-4b17-ba52-e9a86a4f740f	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 [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
21695-169	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110104_74ce605d-b493-4b95-9d59-9253f81f4e20.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	Status
21695-169-30	21695016930	30 in 1 BOTTLE	Historical
21695-169-60	21695016960	60 in 1 BOTTLE	Historical