memantine hydrochloride

Product NDC: 47335-033
Requested package NDC: 47335-033-81
11-digit product format: 473350033
Labeler code: 47335
Product ID: 47335-033_1f7269e6-8156-45be-ba04-9f81cfe7e409
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA205905
Marketing category: ANDA
Marketing start: 2013-06-14
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 21 mg/1
Pharmacologic classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47335-033	47335-033-81	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A205905-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28
A205905-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28
A205905-003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28
A205905-004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205905-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205905-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205905-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205905-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-09-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205905-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205905-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205905-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205905-004	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A205905-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205905-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205905-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205905-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205905-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205905-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205905-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205905-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205905-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205905-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205905-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205905-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205905-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205905-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205905-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205905-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205905-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205905-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205905-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205905-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47335-033-18	2025-01-30	C162847	48780-1	2cef2736-7e80-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2003
47335-033-81	2025-01-30	C162847	48780-1	2cef2736-7e80-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2003
47335-033-83	2025-01-30	C162847	48780-1	2cef2736-7e80-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-033-18	memantine hydrochloride	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	6
47335-033-81	memantine hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	6
47335-033-83	memantine hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-033	MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Legacy NDC, 3 package rows	20191228_e16a8aa8-f5fd-4db8-abb2-d54e742bb95f.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
996594	memantine HCl 14 MG 24HR Extended Release Oral Capsule	PSN	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996603	memantine HCl 21 MG 24HR Extended Release Oral Capsule	PSN	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996609	memantine HCl 28 MG 24HR Extended Release Oral Capsule	PSN	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996615	memantine HCl 7 MG 24HR Extended Release Oral Capsule	PSN	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996594	24 HR memantine hydrochloride 14 MG Extended Release Oral Capsule	SCD	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996603	24 HR memantine hydrochloride 21 MG Extended Release Oral Capsule	SCD	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996609	24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule	SCD	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996615	24 HR memantine hydrochloride 7 MG Extended Release Oral Capsule	SCD	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996594	memantine hydrochloride 14 MG 24 HR Extended Release Oral Capsule	SY	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996603	memantine hydrochloride 21 MG 24 HR Extended Release Oral Capsule	SY	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996609	memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule	SY	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6
996615	memantine hydrochloride 7 MG 24 HR Extended Release Oral Capsule	SY	e16a8aa8-f5fd-4db8-abb2-d54e742bb95f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-033-81	47335003381	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-033-81)	2013-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
memantine hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2019-12-27	Human Prescription Drug Label	6