Memantine Hydrochloride

Product NDC: 63629-2513
11-digit product format: 636292513
Labeler code: 63629
Product ID: 63629-2513_0259deac-9c4d-47b5-a33f-3f4ca4348efe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090961
Marketing category: ANDA
Marketing start: 2019-02-28
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 5 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
A090961-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-07-10
A090961-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2017-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090961-001	AB
A090961-002	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 2 · 80 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
2025-12-14 10:44 UTC	2025-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC	2025-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2017-07-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-07-10	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC	2025-12	A090961-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC	2025-12	A090961-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090961-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090961-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090961-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090961-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090961-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090961-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090961-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090961-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090961-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090961-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090961-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090961-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090961-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090961-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090961-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090961-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090961-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090961-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090961-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090961-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090961-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090961-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090961-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090961-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090961-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090961-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090961-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090961-002	AB	1	`87673890dc5c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	REMEDYREPACK INC.	cbfd9d95-f50b-45ff-9857-9f1712c45e56	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	DirectRx	d0839a2d-35f1-1f14-e053-2995a90ad549	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3662b11a-354a-b683-e063-6394a90a0086	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Coupler LLC	2d54be77-75b2-76b3-e063-6294a90a0cc0	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Lifesciences Limited	514421f3-f525-43e8-aecc-8b2bbffd00dc	2024-08-16		Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	f05e381f-850d-42ea-9dd8-6d1f8dac4f62	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	0ad2246a-ffa0-43a0-8094-58279d3e3a74	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	be919d34-e9f4-49c8-8145-2dcafb7cb88c	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	9cfddd01-6e1d-4ee0-9310-3fb371724e3d	2023-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	bf395152-2885-4633-bf3f-2da46e7b79f1	2023-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	8bd5b908-f46a-4ced-9408-45984d716149	2023-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 63629-2513
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	54a12ddf-306b-4eb7-a7c3-c7b58df3b372	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	fac8c59b-5bf5-478e-8223-a5ecaa400625	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	c8f96b24-de66-4a17-b798-42b42a25e84c	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Viona Pharmaceuticals Inc	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	5 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
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
2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	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
63629-2513-1	Memantine Hydrochloride	500 in 1 BOTTLE	TABLET	500		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2513-1	EA - Each	63629-2513	d1ba2261-1bc3-4cf1-a45c-f1aa8f16877f	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2513	MEMANTINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 1 package rows	20230306_2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0.zip

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
996571	memantine HCl 5 MG Oral Tablet	PSN	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	102
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2513-1	63629251301	500 TABLET in 1 BOTTLE (63629-2513-1)	500 tablet	2021-05-18	0000-00-00	No	No	Current