memantine hydrochloride

Generic: memantine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-321
Product ID 47335-321_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090058
Listing Expiration 2026-12-31
Marketing Start 2015-07-11

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 47335321
Hyphenated Format 47335-321

Supplemental Identifiers

RxCUI
996561 996571
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 ANDA090058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-321-18)
  • 60 TABLET, FILM COATED in 1 BOTTLE (47335-321-86)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-88)
source: ndc

Packages (4)

47335-321-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08) 47335-321-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-321-18) 47335-321-86 60 TABLET, FILM COATED in 1 BOTTLE (47335-321-86) 47335-321-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-88)

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": "81ca8cbf-7854-43a2-bd0b-1dbaf4709a42", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["d1963395-3cf7-4433-bf2c-06295bb1c5b0"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08)", "package_ndc": "47335-321-08", "marketing_start_date": "20150711"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-321-18)", "package_ndc": "47335-321-18", "marketing_start_date": "20150711"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (47335-321-86)", "package_ndc": "47335-321-86", "marketing_start_date": "20150711"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-321-88)", "package_ndc": "47335-321-88", "marketing_start_date": "20150711"}], "brand_name": "Memantine Hydrochloride", "product_id": "47335-321_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "47335-321", "generic_name": "Memantine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090058", "marketing_category": "ANDA", "marketing_start_date": "20150711", "listing_expiration_date": "20261231"}