Memantine

Product NDC: 70518-3297
Requested package NDC: 70518-3297-0
11-digit product format: 705183297
Labeler code: 70518
Product ID: 70518-3297_d348a442-d06d-ca26-e053-2995a90a8525
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA090048
Marketing category: ANDA
Marketing start: 2021-12-15
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	70518-3297	70518-3297-0	D	Discontinued by firm		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 · 12 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…`

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
A090048-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-04-14
A090048-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2010-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090048-001	AB
A090048-002	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	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`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	A090048-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090048-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090048-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090048-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090048-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090048-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090048-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090048-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090048-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090048-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090048-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090048-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090048-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090048-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090048-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090048-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090048-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090048-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3297-0	2023-03-23	C162847	48780-1	f386c64a-3f21-0266-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
70518-3297-0	2023-01-30	C162847	48780-1	f386c64a-3f21-0266-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

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Major Pharmaceuticals	d0a5e0fc-04e3-417d-bef3-9b309ff71597	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	65c9e7bc-71f0-4113-8de1-4fcaa591735f	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048
Memantine	MEMANTINE	American Health Packaging	304a3059-4f7f-4ec4-839d-86492bb5e07b	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048
Memantine	MEMANTINE	NCS HealthCare of KY, LLC dba Vangard Labs	a5dcc0e7-761f-4294-bb48-e5ee4a1e2f67	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048
Memantine	MEMANTINE	NCS HealthCare of KY, LLC dba Vangard Labs	5c8a168d-aef5-4ac7-b8c1-3812a8c228ab	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048
Memantine	MEMANTINE	NorthStar RxLLC	7a40ed9d-8853-b616-ff47-0c7b0fd28959	2023-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Dr. Reddys Laboratories Limited	a71e2482-5266-d03e-8b36-862afe78c9a4	2019-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE
W8O17SJF3T	MEMANTINE	19982-08-2	Memantine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3297-0	70518329700	30 TABLET in 1 BOTTLE, PLASTIC (70518-3297-0)	30 tablet	2021-12-15	0000-00-00	No	No	Current