memantine hydrochloride

Generic: memantine hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 14 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-783
Product ID 65162-783_fb7782a5-2357-4a21-86a6-0eeaa7cdcea5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205825
Listing Expiration 2026-12-31
Marketing Start 2017-12-22

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 65162783
Hyphenated Format 65162-783

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
UPC
0365162784091 0365162783094 0365162785098 0365162782097
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 (source: ndc)
Application Number ANDA205825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 14 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-03)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-09)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-50)
source: ndc

Packages (3)

65162-783-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-03) 65162-783-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-09) 65162-783-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-50)

Ingredients (1)

memantine hydrochloride (14 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": "fb7782a5-2357-4a21-86a6-0eeaa7cdcea5", "openfda": {"upc": ["0365162784091", "0365162783094", "0365162785098", "0365162782097"], "unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["f2b7538d-8ca1-4ac7-a172-d268e2fa9a52"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-03)", "package_ndc": "65162-783-03", "marketing_start_date": "20171222"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-09)", "package_ndc": "65162-783-09", "marketing_start_date": "20171222"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-50)", "package_ndc": "65162-783-50", "marketing_start_date": "20171222"}], "brand_name": "Memantine Hydrochloride", "product_id": "65162-783_fb7782a5-2357-4a21-86a6-0eeaa7cdcea5", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "65162-783", "generic_name": "Memantine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "14 mg/1"}], "application_number": "ANDA205825", "marketing_category": "ANDA", "marketing_start_date": "20171222", "listing_expiration_date": "20261231"}