memantine hydrochloride

Generic: memantine hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1120
Product ID 70771-1120_71694aca-1930-42bc-8322-6470fd047953
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090961
Listing Expiration 2026-12-31
Marketing Start 2017-09-28

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 707711120
Hyphenated Format 70771-1120

Supplemental Identifiers

RxCUI
996561 996571
UPC
0372578004057 0372578003050
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 ANDA090961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1120-0)
  • 100 TABLET, FILM COATED in 1 BOTTLE (70771-1120-1)
  • 1000 BLISTER PACK in 1 CARTON (70771-1120-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70771-1120-2)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70771-1120-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (70771-1120-6)
source: ndc

Packages (5)

70771-1120-0 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1120-0) 70771-1120-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1120-1) 70771-1120-4 1000 BLISTER PACK in 1 CARTON (70771-1120-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70771-1120-2) 70771-1120-5 500 TABLET, FILM COATED in 1 BOTTLE (70771-1120-5) 70771-1120-6 60 TABLET, FILM COATED in 1 BOTTLE (70771-1120-6)

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": "71694aca-1930-42bc-8322-6470fd047953", "openfda": {"upc": ["0372578004057", "0372578003050"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["514421f3-f525-43e8-aecc-8b2bbffd00dc"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70771-1120-0)", "package_ndc": "70771-1120-0", "marketing_start_date": "20170928"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1120-1)", "package_ndc": "70771-1120-1", "marketing_start_date": "20170928"}, {"sample": false, "description": "1000 BLISTER PACK in 1 CARTON (70771-1120-4)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (70771-1120-2)", "package_ndc": "70771-1120-4", "marketing_start_date": "20170928"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70771-1120-5)", "package_ndc": "70771-1120-5", "marketing_start_date": "20170928"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (70771-1120-6)", "package_ndc": "70771-1120-6", "marketing_start_date": "20170928"}], "brand_name": "Memantine Hydrochloride", "product_id": "70771-1120_71694aca-1930-42bc-8322-6470fd047953", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "70771-1120", "generic_name": "Memantine Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090961", "marketing_category": "ANDA", "marketing_start_date": "20170928", "listing_expiration_date": "20261231"}