Memantine Hydrochloride

Product NDC: 0121-0850
Requested package NDC: 0121-0850-40
11-digit product format: 001210850
Labeler code: 0121
Product ID: 0121-0850_ed854db7-e85c-fb08-e053-2a95a90aaf92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
Application: ANDA204033
Marketing category: ANDA
Marketing start: 2019-04-15
Marketing end: 2024-05-31
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 10 mg/5mL
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0121-0850	0121-0850-40	D	Discontinued by firm		2026-08-03

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

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 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204033-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	RS	2015-10-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A204033-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204033-001	AA	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0121-0850-40	2022-11-15	C162847	48780-1	d6a99b39-848f-a426-e053-dadaa90af4c2	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
0121-0850-40	2022-01-28	C162847	48780-1	d6a99b39-848f-a426-e053-dadaa90af4c2	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0850-05	ML - Milliliter	0121-0850	48051d3b-0536-4bb2-a91a-7688e6918d95	1	2019-09-05
0121-0850-40	ML - Milliliter	0121-0850	70ee6438-817f-4f8a-94ec-f0c87dd10c83	1	2019-09-05

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
0121-0850-40	00121085040	4 TRAY in 1 CASE (0121-0850-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0850-05)	4 tray	2019-04-15	0000-00-00	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