memantine hydrochloride

Generic: memantine hydrochloride oral

Labeler: seton pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride oral
Labeler seton pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

memantine hydrochloride 2 mg/mL

Manufacturer
Seton Pharmaceuticals

Identifiers & Regulatory

Product NDC 13925-540
Product ID 13925-540_cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210319
Marketing Start 2020-08-31
Marketing End 2027-03-31

Pharmacologic Class

Classes
n-methyl-d-aspartate receptor antagonist [epc] nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13925540
Hyphenated Format 13925-540

Supplemental Identifiers

RxCUI
996740
UNII
JY0WD0UA60

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name memantine hydrochloride (source: ndc)
Generic Name memantine hydrochloride oral (source: ndc)
Application Number ANDA210319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 360 mL in 1 BOTTLE (13925-540-12)
source: ndc

Packages (1)

13925-540-12 360 mL in 1 BOTTLE (13925-540-12)

Ingredients (1)

memantine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Memantine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996740"], "spl_set_id": ["421f6478-09df-49d3-a7c4-52814b4aa90e"], "manufacturer_name": ["Seton Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "360 mL in 1 BOTTLE (13925-540-12)", "package_ndc": "13925-540-12", "marketing_end_date": "20270331", "marketing_start_date": "20210519"}], "brand_name": "Memantine Hydrochloride", "product_id": "13925-540_cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9", "dosage_form": "SOLUTION", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "13925-540", "generic_name": "Memantine Hydrochloride Oral", "labeler_name": "Seton Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA210319", "marketing_category": "ANDA", "marketing_end_date": "20270331", "marketing_start_date": "20200831"}