Memantine Hydrochloride

Product NDC: 50268-587
11-digit product format: 502680587
Labeler code: 50268
Product ID: 50268-587_47e7cea9-cd6c-40d4-e063-6294a90a9e8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA200022
Marketing category: ANDA
Marketing start: 2024-02-20
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A200022-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-10-13
A200022-002	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
A200022-001	AB
A200022-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200022-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200022-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200022-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200022-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200022-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200022-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200022-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200022-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200022-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200022-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200022-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200022-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200022-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200022-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200022-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200022-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200022-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200022-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Memantine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JY0WD0UA60	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996561	Internal RxNorm lookup
996571	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
11d27c75-fdc0-f9da-e063-6394a90ac6b0	Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	Strength	SPL version
50268-587-11	Memantine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
50268-587-13	Memantine Hydrochloride	30 in 1 BOX	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-587-11	EA - Each	50268-587	6a4a9dea-6c96-4103-b098-d44557dd70bb	1	2024-04-05
50268-587-13	EA - Each	50268-587	683940de-4acb-4fa3-9559-3ed7e1077ffc	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-587	MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]	1	Current NDC, 2 package rows	20240307_11d27c75-fdc0-f9da-e063-6394a90ac6b0.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	47e4a696-fe2a-c905-e063-6294a90a7415	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	AvPAK	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022 ndc (product): 50268-587
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	ca619439-f4ca-43f1-9261-9aa2b6dc7450	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	2fdf0b2b-0337-472d-83ec-075c17c9b0d0	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90	2020-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022

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	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2
996571	memantine HCl 5 MG Oral Tablet	PSN	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-587-11	50268058711	1 in 1 BLISTER PACK					Historical
50268-587-13	50268058713	30 BLISTER PACK in 1 BOX (50268-587-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-587-11)	30 blister pack	2024-02-20	No	No	Current