Memantine

Product NDC: 60687-184
11-digit product format: 606870184
Labeler code: 60687
Product ID: 60687-184_33621ba6-ed39-5bf8-e063-6394a90ab7e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA090048
Marketing category: ANDA
Marketing start: 2015-09-09
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Memantine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	10 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
304a3059-4f7f-4ec4-839d-86492bb5e07b	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
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
60687-184-11	Memantine	1 in 1 BLISTER PACK	TABLET	1		7
60687-184-57	Memantine	60 in 1 BOX, UNIT-DOSE	TABLET	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-184-11	EA - Each	60687-184	338524c9-f1bb-4195-9f74-aa8b65571a54	1	2015-10-02
60687-184-57	EA - Each	60687-184	244c3cae-4ef9-42af-ada4-9f3ce907ece8	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Memantine Hydrochloride	ACTIVE INGREDIENT	JY0WD0UA60	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Memantine	ACTIVE MOIETY	W8O17SJF3T	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Fd&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Fd&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-184	MEMANTINE TABLET [AMERICAN HEALTH PACKAGING]	7	Current NDC, Legacy NDC, 2 package rows	20250424_304a3059-4f7f-4ec4-839d-86492bb5e07b.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 · 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 ndc (product): 60687-184
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996561	memantine HCl 10 MG Oral Tablet	PSN	304a3059-4f7f-4ec4-839d-86492bb5e07b	7
996571	memantine HCl 5 MG Oral Tablet	PSN	304a3059-4f7f-4ec4-839d-86492bb5e07b	7
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	304a3059-4f7f-4ec4-839d-86492bb5e07b	7
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	304a3059-4f7f-4ec4-839d-86492bb5e07b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-184-11	60687018411	1 in 1 BLISTER PACK						Historical
60687-184-57	60687018457	60 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-184-57) / 1 TABLET in 1 BLISTER PACK (60687-184-11)	60 blister pack	2015-09-09	0000-00-00	No	No	Current