Memantine Hydrochloride

Product NDC: 43353-165
11-digit product format: 433530165
Labeler code: 43353
Product ID: 43353-165_bd5eaa03-d2d2-4af4-855f-a3fa51a58b72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA200891
Marketing category: ANDA
Marketing start: 2015-10-13
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: 2020-12-31
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	43353-165		D	Discontinued by firm	2026-10-05
excluded package	package	43353-165	43353-165-18	D	Discontinued by firm	2026-10-05
excluded package	package	43353-165	43353-165-53	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
A200891-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-10-13
A200891-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200891-001	AB
A200891-002	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 3 · 86 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	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A200891-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200891-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200891-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200891-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200891-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200891-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200891-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200891-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200891-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200891-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200891-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200891-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200891-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200891-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200891-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200891-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200891-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200891-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-165-18	EA - Each	43353-165	04c13742-91c8-4875-be07-315e6055f1fc	1	2016-08-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-165	MEMANTINE HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20171003_7c093eec-e73f-42aa-acef-101e3d6d039e.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	b86c0f6e-480b-40e7-aa4d-21bd0659101d	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200891 application number: ANDA200891
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	af2b73da-1be4-4b7f-929b-acb3b9a10f78	2021-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200891 application number: ANDA200891

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	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-165-18	43353016518	3000 TABLET, COATED in 1 BOTTLE (43353-165-18)	2016-03-30	0000-00-00	No	No	Current
43353-165-53	43353016553	60 TABLET, COATED in 1 BOTTLE (43353-165-53)	2016-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2017-06-20	Human Prescription Drug Label	2