Memantine HCL

Product NDC: 72189-538
11-digit product format: 721890538
Labeler code: 72189
Product ID: 72189-538_1289db0e-517a-d157-e063-6294a90ab758
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine HCL
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA206528
Marketing category: ANDA
Marketing start: 2024-02-29
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 44.

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
A206528-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-11-30
A206528-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206528-001	AB
A206528-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206528-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206528-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206528-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206528-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206528-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206528-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206528-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206528-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206528-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206528-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206528-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206528-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206528-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206528-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206528-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206528-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206528-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206528-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206528-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206528-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206528-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206528-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206528-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206528-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206528-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206528-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206528-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206528-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206528-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206528-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206528-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206528-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206528-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206528-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206528-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206528-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206528-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206528-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206528-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206528-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Memantine HCL
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996561	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
1289db0e-5179-d157-e063-6294a90ab758	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
72189-538-60	Memantine HCL	60 in 1 BOTTLE	TABLET	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-538-60	EA - Each	72189-538	13fb908b-29c7-44c4-abaf-98ccd1f38480	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-538	MEMANTINE HCL TABLET [DIRECT_RX]	1	Current NDC, 1 package rows	20240302_1289db0e-5179-d157-e063-6294a90ab758.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	becb09dc-174d-4817-88d4-f38c8adcd309	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	afc07196-be28-4521-afc0-d4aa5b6fd46d	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	292671f2-f221-4a3d-a110-a266a9527e04	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b8b982-db74-7cf4-e063-6394a90a3a6b	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528
Memantine HCL	MEMANTINE HCL	Direct_Rx	1289db0e-5179-d157-e063-6294a90ab758	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528 ndc (product): 72189-538
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	d1c2ec99-7183-46e3-a96e-4f23e20b8b06	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528

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	1289db0e-5179-d157-e063-6294a90ab758	1
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	1289db0e-5179-d157-e063-6294a90ab758	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-538-60	72189053860	60 TABLET in 1 BOTTLE (72189-538-60)	60 tablet	2024-02-29	No	No	Current