Generic Drug

Product NDC: 72994-001
Requested package NDC: 72994-001-11
11-digit product format: 729940001
Labeler code: 72994
Product ID: 72994-001_8856b53a-905d-3947-e053-2a95a90ae82b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride Tablets
Dosage form: TABLET
Route: ORAL
Labeler: Ningbo Shouzheng Medicinal Research Co., Ltd
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2020-04-06
Marketing end: 2030-04-17
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
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	72994-001	72994-001-11	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
5b597f00-4538-4686-aa4e-3c60ed3788c8	Product name	2	20210511
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
1836e79a-a4d1-4087-2f2e-f878e8a1fef2	Product name	9	20151209
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72994-001-11	2024-01-30	C162847	48780-1	1030e365-6550-111a-e063-dadaa90a10e2	802cbfd0-0dbe-638f-e053-2991aa0a6841

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72994-001-11	Generic Drug	60 in 1 BOTTLE, PLASTIC	TABLET	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72994-001	GENERIC DRUG (MEMANTINE HYDROCHLORIDE TABLETS) TABLET [NINGBO SHOUZHENG MEDICINAL RESEARCH CO., LTD]	3	Legacy NDC, 1 package rows	20200406_802cbfd0-0dbe-638f-e053-2991aa0a6841.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
996561	memantine HCl 10 MG Oral Tablet	PSN	802cbfd0-0dbe-638f-e053-2991aa0a6841	3
996571	memantine HCl 5 MG Oral Tablet	PSN	802cbfd0-0dbe-638f-e053-2991aa0a6841	3
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	802cbfd0-0dbe-638f-e053-2991aa0a6841	3
996571	memantine hydrochloride 5 MG Oral Tablet	SCD	802cbfd0-0dbe-638f-e053-2991aa0a6841	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72994-001-11	72994000111	60 TABLET in 1 BOTTLE, PLASTIC (72994-001-11)	60 tablet	2020-04-06	2030-04-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride Tablets	Ningbo Shouzheng Medicinal Research Co., Ltd \| Ningbo Shuangchenemed Pharmaceutical Co., Ltd	2019-05-07	HUMAN PRESCRIPTION DRUG LABEL	3