memantine hydrochloride

Generic: memantine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-911
Product ID 71610-911_3662a842-9689-b3e3-e063-6394a90a15a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090961
Listing Expiration 2026-12-31
Marketing Start 2019-02-28

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 71610911
Hyphenated Format 71610-911

Supplemental Identifiers

RxCUI
996571
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 ANDA090961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-911-60)
  • 120 TABLET in 1 BOTTLE (71610-911-70)
  • 180 TABLET in 1 BOTTLE (71610-911-80)
source: ndc

Packages (3)

71610-911-60 90 TABLET in 1 BOTTLE (71610-911-60) 71610-911-70 120 TABLET in 1 BOTTLE (71610-911-70) 71610-911-80 180 TABLET in 1 BOTTLE (71610-911-80)

Ingredients (1)

memantine hydrochloride (5 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": "3662a842-9689-b3e3-e063-6394a90a15a9", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996571"], "spl_set_id": ["3662b11a-354a-b683-e063-6394a90a0086"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-911-60)", "package_ndc": "71610-911-60", "marketing_start_date": "20250530"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-911-70)", "package_ndc": "71610-911-70", "marketing_start_date": "20250530"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-911-80)", "package_ndc": "71610-911-80", "marketing_start_date": "20250530"}], "brand_name": "Memantine Hydrochloride", "product_id": "71610-911_3662a842-9689-b3e3-e063-6394a90a15a9", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "71610-911", "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": "5 mg/1"}], "application_number": "ANDA090961", "marketing_category": "ANDA", "marketing_start_date": "20190228", "listing_expiration_date": "20261231"}