Memantine Hydrochloride

Product NDC: 50090-4877
11-digit product format: 500904877
Labeler code: 50090
Product ID: 50090-4877_8eddd09c-6a44-4043-b28d-8acc38c306aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA207236
Marketing category: ANDA
Marketing start: 2016-11-10
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: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4877-0	2023-01-30	C162847	48780-1	f386c649-d89c-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4877-0	Memantine Hydrochloride	90 in 1 BOTTLE	TABLET	90		3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4877	MEMANTINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 1 package rows	20200226_a5c3eba1-604b-4662-a718-0b7ebb958227.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996561	memantine HCl 10 MG Oral Tablet	PSN	a5c3eba1-604b-4662-a718-0b7ebb958227	3
996561	memantine hydrochloride 10 MG Oral Tablet	SCD	a5c3eba1-604b-4662-a718-0b7ebb958227	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4877-0	50090487700	90 TABLET in 1 BOTTLE (50090-4877-0)	90 tablet	2020-02-06	0000-00-00	No	No	Current