Namenda

Product NDC: 21695-169
11-digit product format: 216950169
Labeler code: 21695
Product ID: 21695-169_74ce605d-b493-4b95-9d59-9253f81f4e20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: memantine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021487
Marketing category: NDA
Marketing start: 2004-11-17
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-169		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-169	21695-169-30	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-169	21695-169-60	I	Inactivated by FDA	2026-08-03

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 2 · 66 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	21695-169-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-169-60	`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	21695-169-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-169-60	`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	21695-169-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-169-60	`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	21695-169-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-169-60	`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	21695-169-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-169-60	`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	21695-169-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-169-60	`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	21695-169-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-169-60	`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	21695-169-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-169-60	`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	21695-169-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-169-60	`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	21695-169-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-169-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-169-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-169-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-169-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-169-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-169-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-169-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-169-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-169-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-169-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-169-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-169-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-169-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-169-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-169-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-169-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-169-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-169-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-169-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-169-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-169-60	`e2bbac7714bc…`	`27bdfed8d636…`

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

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
N021487-001	NAMENDA	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		RLD	2003-10-16
N021487-002	NAMENDA	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		RLD	2003-10-16

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	N021487-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021487-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021487-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021487-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021487-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021487-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021487-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021487-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021487-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021487-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021487-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021487-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021487-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021487-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021487-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021487-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021487-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021487-002	AB	1	`782e0a99824c…`

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
21695-169-30	2019-09-24	C162847	48780-1	934fe258-4cfe-48b1-e053-8cdaa90a720a	Namenda
21695-169-60	2019-09-24	C162847	48780-1	934fe258-4cfe-48b1-e053-8cdaa90a720a	Namenda

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-169-30	Namenda	30 in 1 BOTTLE	TABLET	30		1
21695-169-60	Namenda	60 in 1 BOTTLE	TABLET	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-169-30	EA - Each	21695-169	a92892f5-dfd1-44a8-ba0a-309ebfd3f897	1	2012-07-24
21695-169-60	EA - Each	21695-169	585c96de-7a3e-4b17-ba52-e9a86a4f740f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEMANTINE HYDROCHLORIDE	ACTIVE INGREDIENT	JY0WD0UA60	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
MEMANTINE	ACTIVE MOIETY	W8O17SJF3T	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-169	NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110104_74ce605d-b493-4b95-9d59-9253f81f4e20.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	e5754973-e73b-4a25-abb4-80f91880f018	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Actavis Pharma, Inc.	72973b46-f307-4a9e-8fb1-ad2cbccfd736	2018-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c8f5c20b-4573-44c5-89fc-4da11b2e1fe1	2017-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487

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	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996571	memantine HCl 5 MG Oral Tablet	PSN	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996563	Namenda 10 MG Oral Tablet	PSN	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996574	Namenda 5 MG Oral Tablet	PSN	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996563	memantine hydrochloride 10 MG Oral Tablet [Namenda]	SBD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996574	memantine hydrochloride 5 MG Oral Tablet [Namenda]	SBD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996563	Namenda 10 MG Oral Tablet	SY	74ce605d-b493-4b95-9d59-9253f81f4e20	1
996574	Namenda 5 MG Oral Tablet	SY	74ce605d-b493-4b95-9d59-9253f81f4e20	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-169-30	21695016930	30 in 1 BOTTLE	Historical
21695-169-60	21695016960	60 in 1 BOTTLE	Historical