MEMANTINE HYDROCHLORIDE

Product NDC: 0615-8662
11-digit product format: 006158662
Labeler code: 0615
Product ID: 0615-8662_c1bd01fa-4fa1-4867-b167-ab79d851f30f
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: ANDA214651
Marketing category: ANDA
Marketing start: 2021-08-09
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
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A214651-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09
A214651-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09
A214651-003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09
A214651-004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214651-001	AB
A214651-002	AB
A214651-003	AB
A214651-004	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 4 · 140 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
2026-09-14 22:38:34	2026-08	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214651-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214651-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214651-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214651-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214651-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214651-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214651-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214651-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214651-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214651-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214651-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214651-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214651-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214651-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214651-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214651-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214651-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214651-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214651-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214651-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214651-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214651-004	AB	1	`5bbf6a4d5a75…`

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 HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	28 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
996609	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
007d4cb9-3fa9-40f3-b5ca-4083eccd6038	Available on FDA.report

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	NCS HealthCare of KY, LLC dba Vangard Labs	007d4cb9-3fa9-40f3-b5ca-4083eccd6038	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214651 application number: ANDA214651 ndc (product): 0615-8662
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	Aurobindo Pharma Limited	2b2dcd54-47e0-494b-85d2-c28c3adbe737	2022-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214651 application number: ANDA214651

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0615-8662-39	00615866239	30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8662-39)	2026-08-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEMANTINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	2026-09-01	HUMAN PRESCRIPTION DRUG LABEL	1