Memantine Hydrochloride

Product NDC: 0378-5435
11-digit product format: 003785435
Labeler code: 0378
Product ID: 0378-5435_642189b4-b4ad-424a-9c89-4dcbde5b2773
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA206032
Marketing category: ANDA
Marketing start: 2018-02-26
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 7 mg/1
Pharmacologic classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0378-5435		D	Discontinued by firm		2026-08-03
excluded package	package	0378-5435	0378-5435-93	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 10 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0378-5435		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-5435	0378-5435-93	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0378-5435		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-5435	0378-5435-93	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0378-5435		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-5435	0378-5435-93	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0378-5435		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-5435	0378-5435-93	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0378-5435		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-5435	0378-5435-93	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206032-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206032-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206032-003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28
A206032-004	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
A206032-001	AB
A206032-002	AB
A206032-003	AB
A206032-004	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 · 164 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	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-004	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	A206032-001	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	A206032-002	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	A206032-003	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	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-004	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	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206032-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206032-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206032-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206032-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-09-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A206032-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206032-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206032-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206032-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206032-004	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A206032-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206032-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206032-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206032-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206032-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206032-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206032-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206032-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206032-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206032-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206032-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206032-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206032-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206032-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206032-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206032-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206032-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206032-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206032-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206032-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206032-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206032-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206032-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206032-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206032-004	AB	1	`b00525d2431f…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE	Rising Pharma Holdings, Inc.	a282fbed-8304-458e-a0e9-5eaccc95339b	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206032 application number: ANDA206032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5435-93	EA - Each	0378-5435	91a719ae-c282-4af2-b336-d9a5cbd25298	1	2018-03-08

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-5435-93	00378543593	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5435-93)	2018-02-26	0000-00-00	No	No	Current