Memantine Hydrochloride

Product NDC: 72606-515
11-digit product format: 726060515
Labeler code: 72606
Product ID: 72606-515_c46fb7ce-bb2c-48ef-84ac-9da1a7fec412
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CELLTRION USA, INC.
Application: ANDA090073
Marketing category: ANDA
Marketing start: 2020-06-05
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	72606-515		D	Discontinued by firm	2026-08-07
excluded package	package	72606-515	72606-515-02	D	Discontinued by firm	2026-08-07
excluded package	package	72606-515	72606-515-04	D	Discontinued by firm	2026-08-07

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 · 27 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	72606-515-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72606-515-02	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	72606-515-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72606-515-02	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	72606-515-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72606-515-02	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	72606-515-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72606-515-02	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	72606-515-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72606-515-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72606-515-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72606-515-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72606-515-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72606-515-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72606-515-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72606-515-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72606-515-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72606-515-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090073-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL			2015-09-04
A090073-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL			2015-09-04

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090073-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090073-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090073-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090073-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090073-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090073-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090073-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090073-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090073-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090073-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090073-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090073-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090073-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090073-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090073-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090073-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090073-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090073-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090073-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090073-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090073-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090073-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090073-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090073-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090073-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090073-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090073-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090073-002	AB	1	`ea99ee380514…`

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, Related label table
NDC	Effective	Related label
72606-515-02	2025-03-14	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
72606-515-04	2025-03-14	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
72606-515-02	2025-01-30	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
72606-515-04	2025-01-30	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. 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
72606-515-02	EA - Each	72606-515	265cd519-fc8e-4b42-9deb-327b4d21526a	1	2020-09-14
72606-515-04	EA - Each	72606-515	3bfe83a8-5308-4f5b-b512-09f295b1d89e	1	2020-09-14

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	6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0	100
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72606-515-02	72606051502	60 TABLET, FILM COATED in 1 BOTTLE (72606-515-02)	2020-06-05	0000-00-00	No	No	Current
72606-515-04	72606051504	500 TABLET, FILM COATED in 1 BOTTLE (72606-515-04)	2020-06-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Bryant Ranch Prepack	2021-10-21	HUMAN PRESCRIPTION DRUG LABEL	100
Memantine Hydrochloride	CELLTRION USA, INC. \| CELLTRION, INC. \| VIVIMED LIFE SCIENCES PRIVATE LIMITED	2020-06-05	HUMAN PRESCRIPTION DRUG LABEL	1