Memantine Hydrochloride

Product NDC: 13925-540
11-digit product format: 139250540
Labeler code: 13925
Product ID: 13925-540_cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride Oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Seton Pharmaceuticals
Application: ANDA210319
Marketing category: ANDA
Marketing start: 2020-08-31
Marketing end: 2027-03-31
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210319-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA		2020-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210319-001	AA

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210319-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210319-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210319-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210319-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210319-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210319-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210319-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210319-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210319-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210319-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210319-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210319-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210319-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210319-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210319-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210319-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210319-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210319-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210319-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210319-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210319-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210319-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210319-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210319-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210319-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210319-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210319-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210319-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210319-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210319-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210319-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210319-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210319-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210319-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210319-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210319-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210319-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210319-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Memantine Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEMANTINE HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JY0WD0UA60	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996740	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
421f6478-09df-49d3-a7c4-52814b4aa90e	Available on FDA.report

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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13925-540-12	2023-06-13	C162847	48780-1	f386c649-dc3f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Memantine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Memantine Hydrochloride Oral Solution.Memantine Hydrochloride Oral Solution, for oral use. Initial U.S. Approval: 2003
13925-540-12	2023-01-30	C162847	48780-1	f386c649-dc3f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Memantine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Memantine Hydrochloride Oral Solution.Memantine Hydrochloride Oral Solution, for oral use. Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13925-540-12	Memantine Hydrochloride	360 mL in 1 BOTTLE	SOLUTION	360		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13925-540-12	ML - Milliliter	13925-540	9b490133-aca9-49ab-85c2-a448e1985051	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13925-540	MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE ORAL) SOLUTION [SETON PHARMACEUTICALS]	4	Current NDC, Legacy NDC, 1 package rows	20240131_421f6478-09df-49d3-a7c4-52814b4aa90e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE ORAL	Seton Pharmaceuticals	421f6478-09df-49d3-a7c4-52814b4aa90e	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210319 application number: ANDA210319 ndc (product): 13925-540

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
996740	memantine HCl 2 MG in 1 mL Oral Solution	PSN	421f6478-09df-49d3-a7c4-52814b4aa90e	5
996740	memantine hydrochloride 2 MG/ML Oral Solution	SCD	421f6478-09df-49d3-a7c4-52814b4aa90e	5
996740	memantine HCl 10 MG per 5 ML Oral Solution	SY	421f6478-09df-49d3-a7c4-52814b4aa90e	5
996740	memantine HCl 2 MG per 1 ML Oral Solution	SY	421f6478-09df-49d3-a7c4-52814b4aa90e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13925-540-12	13925054012	360 mL in 1 BOTTLE (13925-540-12)	360 ml	2021-05-19	2027-03-31	No	No	Current