Memantine hydrochloride

Product NDC: 52605-072
11-digit product format: 526050072
Labeler code: 52605
Product ID: 52605-072_4fe4f372-10c2-42ca-bc69-d78a489672b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: POLYGEN PHARMACEUTICALS INC.
Application: ANDA210587
Marketing category: ANDA
Marketing start: 2021-07-01
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 10 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#

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52605-072		D	Discontinued by firm	2026-10-05
excluded package	package	52605-072	52605-072-10	D	Discontinued by firm	2026-10-05
excluded package	package	52605-072	52605-072-13	D	Discontinued by firm	2026-10-05
excluded package	package	52605-072	52605-072-16	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210587-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2020-12-11
A210587-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2020-12-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210587-001	AB
A210587-002	AB

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 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210587-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-12-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210587-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-12-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210587-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210587-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210587-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210587-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210587-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210587-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210587-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210587-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210587-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210587-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210587-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210587-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210587-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210587-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210587-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210587-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210587-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210587-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210587-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210587-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210587-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210587-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210587-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210587-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210587-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210587-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210587-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210587-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210587-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210587-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210587-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210587-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210587-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210587-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210587-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210587-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210587-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210587-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210587-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210587-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52605-072-10	Memantine hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	4
52605-072-13	Memantine hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
52605-072-16	Memantine hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52605-072	MEMANTINE HYDROCHLORIDE TABLET, FILM COATED MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [POLYGEN PHARMACEUTICALS INC.]	4	Legacy NDC, 3 package rows	20221202_c343b0c5-3bfc-4b94-9483-a56924f6dcdb.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	c343b0c5-3bfc-4b94-9483-a56924f6dcdb	4
996571	memantine HCl 5 MG Oral Tablet	PSN	c343b0c5-3bfc-4b94-9483-a56924f6dcdb	4
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	c343b0c5-3bfc-4b94-9483-a56924f6dcdb	4
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	c343b0c5-3bfc-4b94-9483-a56924f6dcdb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52605-072-10	52605007210	1000 TABLET, FILM COATED in 1 BOTTLE (52605-072-10)	2021-07-01	0000-00-00	No	No	Current
52605-072-13	52605007213	30 TABLET, FILM COATED in 1 BOTTLE (52605-072-13)	2021-07-01	0000-00-00	No	No	Current
52605-072-16	52605007216	60 TABLET, FILM COATED in 1 BOTTLE (52605-072-16)	2021-07-01	0000-00-00	No	No	Current