Memantine Hydrochloride

Product NDC: 67046-458
11-digit product format: 670460458
Labeler code: 67046
Product ID: 67046-458_5a455264-1055-2ddb-e053-2991aa0a66b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA090058
Marketing category: ANDA
Marketing start: 2017-09-28
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67046-458		I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-07	I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-14	I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-15	I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-20	I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-21	I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-28	I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-30	I	Inactivated by FDA	2026-10-15
excluded package	package	67046-458	67046-458-60	I	Inactivated by FDA	2026-10-15

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 4 · 189 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-458-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-458-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-458-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-458-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-458-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-458-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-458-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-458-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-458-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-458-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-458-30	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090058-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-05-05
A090058-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090058-001	AB
A090058-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A090058-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090058-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090058-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090058-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090058-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090058-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090058-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090058-002	AB	1	`a50c72e98297…`

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, Related label table
NDC	Related label
67046-458-07	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-14	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-15	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-20	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-21	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-28	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-30	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-60	458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67046-458-07	Memantine Hydrochloride	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	1
67046-458-14	Memantine Hydrochloride	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	1
67046-458-15	Memantine Hydrochloride	15 in 1 BLISTER PACK	TABLET, FILM COATED	15	1
67046-458-20	Memantine Hydrochloride	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	1
67046-458-21	Memantine Hydrochloride	21 in 1 BLISTER PACK	TABLET, FILM COATED	21	1
67046-458-28	Memantine Hydrochloride	28 in 1 BLISTER PACK	TABLET, FILM COATED	28	1
67046-458-30	Memantine Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	1
67046-458-60	Memantine Hydrochloride	60 in 1 BLISTER PACK	TABLET, FILM COATED	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-458	MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 8 package rows	20170929_5a455264-1054-2ddb-e053-2991aa0a66b0.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	Bryant Ranch Prepack	2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090058 application number: ANDA090058
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d1963395-3cf7-4433-bf2c-06295bb1c5b0	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090058 application number: ANDA090058

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
996561	memantine HCl 10 MG Oral Tablet	PSN	5a455264-1054-2ddb-e053-2991aa0a66b0	1
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	5a455264-1054-2ddb-e053-2991aa0a66b0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67046-458-07	67046045807	7 in 1 BLISTER PACK	Historical
67046-458-14	67046045814	14 in 1 BLISTER PACK	Historical
67046-458-15	67046045815	15 in 1 BLISTER PACK	Historical
67046-458-20	67046045820	20 in 1 BLISTER PACK	Historical
67046-458-21	67046045821	21 in 1 BLISTER PACK	Historical
67046-458-28	67046045828	28 in 1 BLISTER PACK	Historical
67046-458-30	67046045830	30 in 1 BLISTER PACK	Historical
67046-458-60	67046045860	60 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-09-28	HUMAN PRESCRIPTION DRUG LABEL	1