Namenda

Product NDC: 63629-5291
11-digit product format: 636295291
Labeler code: 63629
Product ID: 63629-5291_ae4d77ae-cacb-4ce8-8c2e-8835272fb232
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
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: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-5291		D	Discontinued by firm	2026-08-17
excluded package	package	63629-5291	63629-5291-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-5291	63629-5291-2	D	Discontinued by firm	2026-08-17

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 · 39 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5291-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-5291-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5291-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-5291-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5291-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-5291-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5291-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-5291-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5291-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-5291-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5291-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-5291-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5291-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-5291-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5291-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-5291-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5291-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-5291-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-5291-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-5291-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-5291-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-5291-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-5291-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-5291-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-5291-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-5291-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 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
2026-08-18 06:07:40	2026-07	N021487-001	NAMENDA	5MG	TABLET / ORAL		RLD	2003-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021487-002	NAMENDA	10MG	TABLET / ORAL		RLD	2003-10-16	`caaa826d4ba7…`
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…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-5291-1	2020-10-16	These highlights do not include all the information needed to use NAMENDA safely and effectively. See full prescribing information for NAMENDA . NAMENDA ® (memantine hydrochloride ) tablets, for oral use Initial U.S. Approval: 20 03
63629-5291-2	2020-10-16	These highlights do not include all the information needed to use NAMENDA safely and effectively. See full prescribing information for NAMENDA . NAMENDA ® (memantine hydrochloride ) tablets, for oral use Initial U.S. Approval: 20 03
63629-5291-1	2020-01-31	These highlights do not include all the information needed to use NAMENDA safely and effectively. See full prescribing information for NAMENDA . NAMENDA ® (memantine hydrochloride ) tablets, for oral use Initial U.S. Approval: 20 03
63629-5291-2	2020-01-31	These highlights do not include all the information needed to use NAMENDA safely and effectively. See full prescribing information for NAMENDA . NAMENDA ® (memantine hydrochloride ) tablets, for oral use Initial U.S. Approval: 20 03

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
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]	1000

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
63629-5291-1	63629529101	30 TABLET in 1 BOTTLE (63629-5291-1)	30 tablet	2014-04-01	0000-00-00	No	No	Current
63629-5291-2	63629529102	60 TABLET in 1 BOTTLE (63629-5291-2)	60 tablet	2014-04-01	0000-00-00	No	No	Current