Memantine Hydrochloride

Product NDC: 62980-121
11-digit product format: 629800121
Labeler code: 62980
Product ID: 62980-121_b2acbf19-563c-4995-8ef5-0cee182f2cdf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Vivimed Labs Limited
Application: ANDA090073
Marketing category: ANDA
Marketing start: 2015-09-04
Marketing end: 0000-00-00
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62980-121		I	Inactivated by FDA	2026-10-15
excluded package	package	62980-121	62980-121-01	I	Inactivated by FDA	2026-10-15
excluded package	package	62980-121	62980-121-02	I	Inactivated by FDA	2026-10-15
excluded package	package	62980-121	62980-121-03	I	Inactivated by FDA	2026-10-15
excluded package	package	62980-121	62980-121-06	I	Inactivated by FDA	2026-10-15
excluded package	package	62980-121	62980-121-08	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 3 · 132 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	62980-121-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-121-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-121-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-121-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-121-03	`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	62980-121-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-121-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-121-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-121-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-121-03	`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	62980-121-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-121-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-121-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-121-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-121-03	`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	62980-121-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-121-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-121-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-121-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-121-03	`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	62980-121-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-121-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-121-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-121-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-121-03	`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	62980-121-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-121-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-121-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-121-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-121-03	`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	62980-121-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-121-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-121-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-121-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-121-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-121-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-121-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-121-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-121-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-121-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-121-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-121-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-121-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-121-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-121-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-121-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-121-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-121-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-121-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-121-03	`ad56d346431e…`	`cc804d4bbf1e…`

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
A090073-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL			2015-09-04
A090073-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL			2015-09-04

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	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090073-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090073-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090073-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090073-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090073-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090073-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090073-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090073-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090073-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090073-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090073-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090073-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090073-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090073-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090073-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090073-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090073-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090073-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090073-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090073-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090073-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090073-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090073-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090073-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090073-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090073-002	AB	1	`cb3db0bc1861…`

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
62980-121-01	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-121-02	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-121-03	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-121-06	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
62980-121-08	These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. 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
62980-121-01	Memantine Hydrochloride	30 in 1 BOTTLE	TABLET	30	1
62980-121-02	Memantine Hydrochloride	500 in 1 BOTTLE	TABLET	500	1
62980-121-03	Memantine Hydrochloride	60 in 1 BOTTLE	TABLET	60	1
62980-121-06	Memantine Hydrochloride	12 in 1 CARTON	TABLET	12	1
62980-121-07	Memantine Hydrochloride	24 in 1 BLISTER PACK	TABLET	24	1
62980-121-08	Memantine Hydrochloride	100 in 1 BOTTLE	TABLET	100	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEMANTINE HYDROCHLORIDE	ACTIVE INGREDIENT	JY0WD0UA60	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
MEMANTINE	ACTIVE MOIETY	W8O17SJF3T	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62980-121	MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [VIVIMED LABS LIMITED]	1	Legacy NDC, 6 package rows	20151013_4c5bef01-2e31-4181-a040-bb5a2fec949d.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
996572	{21 (memantine hydrochloride 10 MG Oral Tablet) / 28 (memantine hydrochloride 5 MG Oral Tablet) } Pack	GPCK	4c5bef01-2e31-4181-a040-bb5a2fec949d	1
996561	memantine HCl 10 MG Oral Tablet	PSN	4c5bef01-2e31-4181-a040-bb5a2fec949d	1
996572	memantine HCl 5 MG (28) / 10 MG (21) Tablet Titration Pack	PSN	4c5bef01-2e31-4181-a040-bb5a2fec949d	1
996571	memantine HCl 5 MG Oral Tablet	PSN	4c5bef01-2e31-4181-a040-bb5a2fec949d	1
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	4c5bef01-2e31-4181-a040-bb5a2fec949d	1
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	4c5bef01-2e31-4181-a040-bb5a2fec949d	1
996572	memantine HCl 5 MG (28) / 10 MG (21) Tablet Titration Pack	SY	4c5bef01-2e31-4181-a040-bb5a2fec949d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
62980-121-01	62980012101	30 in 1 BOTTLE	Historical
62980-121-02	62980012102	500 in 1 BOTTLE	Historical
62980-121-03	62980012103	60 in 1 BOTTLE	Historical
62980-121-06	62980012106	12 in 1 CARTON	Historical
62980-121-07	62980012107	24 in 1 BLISTER PACK	Historical
62980-121-08	62980012108	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Vivimed Labs Limited \| Wockhardt Limited \| Vivimed Labs (Alathur) Private Limited	2015-05-27	HUMAN PRESCRIPTION DRUG LABEL	1