memantine hydrochloride

Generic: memantine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-011
Product ID 71610-011_f384e3d8-d9fd-481c-b924-4bf98dfb5bdf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021487
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

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 71610011
Hyphenated Format 71610-011

Supplemental Identifiers

RxCUI
996561
UNII
JY0WD0UA60

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 (source: ndc)
Application Number NDA021487 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3000 TABLET in 1 BOTTLE (71610-011-18)
source: ndc

Packages (1)

71610-011-18 3000 TABLET in 1 BOTTLE (71610-011-18)

Ingredients (1)

memantine hydrochloride (10 mg/1)

Linked Drug Pages (1)

memantine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f384e3d8-d9fd-481c-b924-4bf98dfb5bdf", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561"], "spl_set_id": ["c8f5c20b-4573-44c5-89fc-4da11b2e1fe1"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "3000 TABLET in 1 BOTTLE (71610-011-18)", "package_ndc": "71610-011-18", "marketing_start_date": "20171115"}], "brand_name": "memantine hydrochloride", "product_id": "71610-011_f384e3d8-d9fd-481c-b924-4bf98dfb5bdf", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "71610-011", "generic_name": "memantine hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA021487", "marketing_category": "NDA", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}