memantine hydrochloride

Product NDC: 0615-8264
11-digit product format: 006158264
Labeler code: 0615
Product ID: 0615-8264_194f162d-30bc-420f-85ae-fca98d00705a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA206028
Marketing category: ANDA
Marketing start: 2018-02-20
Marketing end: 2026-07-31
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 28 mg/1
Pharmacologic classes: N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-8264		D	Discontinued by firm		2026-08-17
excluded package	package	0615-8264	0615-8264-39	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206028-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206028-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206028-003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206028-004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206028-001	AB
A206028-002	AB
A206028-003	AB
A206028-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206028-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206028-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206028-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206028-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206028-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206028-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206028-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206028-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206028-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206028-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206028-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206028-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206028-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206028-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206028-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206028-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206028-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206028-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206028-004	AB	1	`d8e5a09893c0…`

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
0615-8264-39	memantine hydrochloride	30 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	30		17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8264	MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	16	Current NDC, Legacy NDC, 1 package rows	20240807_e2a371f6-8bfe-4049-b9ca-0ab3d726379e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	24290655-47f3-4042-a977-a832c5161d2c	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206028 application number: ANDA206028
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Major Pharmaceuticals	f6ce7cca-d245-44f2-986c-2a8d85dbb5fb	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206028 application number: ANDA206028

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
996609	memantine HCl 28 MG 24HR Extended Release Oral Capsule	PSN	e2a371f6-8bfe-4049-b9ca-0ab3d726379e	17
996609	24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule	SCD	e2a371f6-8bfe-4049-b9ca-0ab3d726379e	17
996609	memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule	SY	e2a371f6-8bfe-4049-b9ca-0ab3d726379e	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8264-39	00615826439	30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8264-39)	2019-01-09	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
memantine hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-06	HUMAN PRESCRIPTION DRUG LABEL	17