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, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-979
Product ID 71610-979_47e4a650-9483-bc12-e063-6294a90a695d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200022
Listing Expiration 2027-12-31
Marketing Start 2015-11-01

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 71610979
Hyphenated Format 71610-979

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 ANDA200022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-979-80)
source: ndc

Packages (1)

71610-979-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-979-80)

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": "47e4a650-9483-bc12-e063-6294a90a695d", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996571"], "spl_set_id": ["47e4a696-fe2a-c905-e063-6294a90a7415"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-979-80)", "package_ndc": "71610-979-80", "marketing_start_date": "20260108"}], "brand_name": "Memantine Hydrochloride", "product_id": "71610-979_47e4a650-9483-bc12-e063-6294a90a695d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "71610-979", "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": "ANDA200022", "marketing_category": "ANDA", "marketing_start_date": "20151101", "listing_expiration_date": "20271231"}