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

Additional Listing Data#

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

Field, Values table
Field	Values
Unii	JY0WD0UA60
Rxcui	996740

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

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

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

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

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

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
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

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