Memantine Hydrochloride

Product NDC: 0527-1222
11-digit product format: 005271222
Labeler code: 0527
Product ID: 0527-1222_5931403d-152d-43b3-b6df-941c580affa8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA207236
Marketing category: ANDA
Marketing start: 2016-11-10
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	0527-1222		D	Discontinued by firm	2026-08-17
excluded package	package	0527-1222	0527-1222-05	D	Discontinued by firm	2026-08-17
excluded package	package	0527-1222	0527-1222-06	D	Discontinued by firm	2026-08-17
excluded package	package	0527-1222	0527-1222-10	D	Discontinued by firm	2026-08-17

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
A207236-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL			2016-11-10
A207236-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL			2016-11-10

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	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2016-11-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2016-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-11-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-11-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-11-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-11-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207236-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-11-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207236-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-11-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207236-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207236-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207236-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207236-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207236-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207236-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207236-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207236-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207236-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207236-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207236-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207236-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207236-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207236-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207236-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207236-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207236-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207236-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207236-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207236-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207236-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207236-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207236-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207236-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207236-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207236-002	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207236-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207236-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207236-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207236-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207236-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A207236-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207236-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207236-002	AB	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0527-1222-05	2024-01-30	C162847	48780-1	1030e365-38f7-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003
0527-1222-06	2024-01-30	C162847	48780-1	1030e365-38f7-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003
0527-1222-10	2024-01-30	C162847	48780-1	1030e365-38f7-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1222-05	EA - Each	0527-1222	21975011-349a-416d-8941-6a4177dea21c	1	2018-08-13
0527-1222-06	EA - Each	0527-1222	9eb3ce1a-ff3a-4ff6-b7b4-a08fee7b59d1	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1222	MEMANTINE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]	10	Legacy NDC	20240704_88b7952b-b58a-495e-aa19-d3392d2e2759.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	a5c3eba1-604b-4662-a718-0b7ebb958227	3
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	a5c3eba1-604b-4662-a718-0b7ebb958227	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1222-05	00527122205	500 TABLET in 1 BOTTLE, PLASTIC (0527-1222-05)	500 tablet	2016-11-10	0000-00-00	No	No	Current
0527-1222-06	00527122206	60 TABLET in 1 BOTTLE, PLASTIC (0527-1222-06)	60 tablet	2016-11-10	0000-00-00	No	No	Current
0527-1222-10	00527122210	1000 TABLET in 1 BOTTLE, PLASTIC (0527-1222-10)	1000 tablet	2016-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	A-S Medication Solutions	2020-02-25	HUMAN PRESCRIPTION DRUG LABEL	3
Memantine Hydrochloride	Golden State Medical Supply, Inc.	2019-12-02	HUMAN PRESCRIPTION DRUG LABEL	1
Memantine Hydrochloride	Lannett Company, Inc.	2018-10-12	HUMAN PRESCRIPTION DRUG LABEL	10