memantine hydrochloride

Generic: memantine hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

memantine hydrochloride 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-653
Product ID 65862-653_12f3b127-625b-4c19-99f5-54f0ddc5cdc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203175
Listing Expiration 2026-12-31
Marketing Start 2015-10-13

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 65862653
Hyphenated Format 65862-653

Supplemental Identifiers

RxCUI
996561 996571
UPC
0365862653604
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 ANDA203175 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-653-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10)
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-653-60)
  • 10 BLISTER PACK in 1 CARTON (65862-653-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-653-99)
source: ndc

Packages (4)

65862-653-03 3 BLISTER PACK in 1 CARTON (65862-653-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10) 65862-653-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-653-60) 65862-653-78 10 BLISTER PACK in 1 CARTON (65862-653-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10) 65862-653-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-653-99)

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": "12f3b127-625b-4c19-99f5-54f0ddc5cdc0", "openfda": {"upc": ["0365862653604"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["ceb733fa-4526-4b76-ab6a-bd4c5638afff"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-653-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10)", "package_ndc": "65862-653-03", "marketing_start_date": "20151013"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-653-60)", "package_ndc": "65862-653-60", "marketing_start_date": "20151013"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-653-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10)", "package_ndc": "65862-653-78", "marketing_start_date": "20151013"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-653-99)", "package_ndc": "65862-653-99", "marketing_start_date": "20151013"}], "brand_name": "Memantine Hydrochloride", "product_id": "65862-653_12f3b127-625b-4c19-99f5-54f0ddc5cdc0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "65862-653", "generic_name": "Memantine Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA203175", "marketing_category": "ANDA", "marketing_start_date": "20151013", "listing_expiration_date": "20261231"}