Namenda

Product NDC: 55289-937
Requested package NDC: 55289-937-60
11-digit product format: 552890937
Labeler code: 55289
Product ID: 55289-937_d29462f1-443a-106d-e053-2a95a90ac7d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA021487
Marketing category: NDA
Marketing start: 2003-10-16
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: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55289-937	55289-937-60	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-937-30	EA - Each	55289-937	51ec02cc-6387-4bba-a114-139e38ea8d5f	1	2012-07-24
55289-937-60	EA - Each	55289-937	414c39e8-d904-475c-bc70-9084f3519523	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 [PD-RX PHARMACEUTICALS, INC.]	6
MEMANTINE	ACTIVE MOIETY	W8O17SJF3T	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-937-60	55289093760	60 TABLET in 1 BOTTLE, PLASTIC (55289-937-60)	60 tablet	2015-11-05	0000-00-00	No	No	Current