Memantine Hydrochloride

Product NDC: 43353-170
Requested package NDC: 43353-170-18
11-digit product format: 433530170
Labeler code: 43353
Product ID: 43353-170_d8a379ae-6534-4ff3-9432-ae292b8b2472
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA090043
Marketing category: ANDA
Marketing start: 2015-07-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-170	43353-170-18	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A090043-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-07-31
A090043-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090043-001	AB
A090043-002	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 · 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	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090043-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090043-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-07-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090043-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090043-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090043-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090043-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090043-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090043-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090043-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090043-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090043-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090043-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090043-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090043-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090043-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090043-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090043-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090043-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090043-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090043-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090043-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090043-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090043-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090043-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090043-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090043-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090043-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090043-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090043-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090043-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090043-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090043-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090043-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090043-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090043-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090043-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090043-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090043-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090043-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090043-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090043-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090043-002	AB	1	`782e0a99824c…`

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
43353-170-18	2023-01-30	C162847	48780-1	f386c649-e8a1-0266-e053-dadaa90a7c1a	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-170-18	Memantine Hydrochloride	3000 in 1 BOTTLE	TABLET, FILM COATED	3000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-170-18	EA - Each	43353-170	d6d2cf7c-00b4-4b8a-b2e5-b404976931c2	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-170	MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Legacy NDC, 1 package rows	20191219_ab78bc21-87e3-4ce9-ba41-ac337ffae606.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	6e0ade9e-b721-4701-bcb7-de464e19e707	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090043 application number: ANDA090043

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	ab78bc21-87e3-4ce9-ba41-ac337ffae606	4
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	ab78bc21-87e3-4ce9-ba41-ac337ffae606	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-170-18	43353017018	3000 TABLET, FILM COATED in 1 BOTTLE (43353-170-18)	2016-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	4