Memantine Hydrochloride

Product NDC: 0527-1943
Requested package NDC: 0527-1943-13
11-digit product format: 005271943
Labeler code: 0527
Product ID: 0527-1943_bd33c8de-5194-4b37-8a5f-c2b691d6aa5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA204033
Marketing category: ANDA
Marketing start: 2015-10-13
Marketing end: 2024-05-31
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
Listing certified through: 0000-00-00
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	0527-1943	0527-1943-13	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204033-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204033-001	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.

Product history page 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA		2015-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA		2015-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA		2015-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204033-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204033-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204033-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204033-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204033-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204033-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204033-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204033-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204033-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204033-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204033-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204033-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204033-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204033-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204033-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204033-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204033-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204033-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204033-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204033-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204033-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204033-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204033-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204033-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204033-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204033-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204033-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204033-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204033-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204033-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204033-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204033-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204033-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204033-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204033-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204033-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204033-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204033-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204033-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204033-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1943-13	ML - Milliliter	0527-1943	05710f91-abf8-4d7f-8572-ab906cc38103	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEMANTINE HYDROCHLORIDE	ACTIVE INGREDIENT	JY0WD0UA60	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
MEMANTINE	ACTIVE MOIETY	W8O17SJF3T	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
SODIUM CITRATE, UNSPECIFIED FORM	INACTIVE INGREDIENT	1Q73Q2JULR	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]	11

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	Chartwell Governmental & Specialty RX, LLC.	d1f97615-e888-421e-b50a-95a87a1965ff	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204033 application number: ANDA204033
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Chartwell RX, LLC	a7b76864-6de7-45f6-be5b-5ecfca811627	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204033 application number: ANDA204033

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1943-13	00527194313	360 mL in 1 BOTTLE, PLASTIC (0527-1943-13)	360 ml	2015-10-13	2024-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Pharmaceutical Associates, Inc.	2022-11-15	HUMAN PRESCRIPTION DRUG LABEL	3
Memantine Hydrochloride	Lannett Company, Inc.	2021-04-30	HUMAN PRESCRIPTION DRUG LABEL	18