memantine hydrochloride

Generic: memantine hydrochloride

Labeler: polygen pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler polygen pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
POLYGEN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 52605-072
Product ID 52605-072_4fe4f372-10c2-42ca-bc69-d78a489672b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210587
Listing Expiration 2026-12-31
Marketing Start 2021-07-01

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 52605072
Hyphenated Format 52605-072

Supplemental Identifiers

RxCUI
996561 996571
UPC
0352605072105 0352605071139 0352605071108
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 ANDA210587 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (52605-072-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (52605-072-13)
  • 60 TABLET, FILM COATED in 1 BOTTLE (52605-072-16)
source: ndc

Packages (3)

52605-072-10 1000 TABLET, FILM COATED in 1 BOTTLE (52605-072-10) 52605-072-13 30 TABLET, FILM COATED in 1 BOTTLE (52605-072-13) 52605-072-16 60 TABLET, FILM COATED in 1 BOTTLE (52605-072-16)

Ingredients (1)

memantine hydrochloride (10 mg/1)

Linked Drug Pages (1)

memantine hydrochloride, Memantine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4fe4f372-10c2-42ca-bc69-d78a489672b2", "openfda": {"upc": ["0352605072105", "0352605071139", "0352605071108"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["c343b0c5-3bfc-4b94-9483-a56924f6dcdb"], "manufacturer_name": ["POLYGEN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (52605-072-10)", "package_ndc": "52605-072-10", "marketing_start_date": "20210701"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (52605-072-13)", "package_ndc": "52605-072-13", "marketing_start_date": "20210701"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (52605-072-16)", "package_ndc": "52605-072-16", "marketing_start_date": "20210701"}], "brand_name": "Memantine hydrochloride", "product_id": "52605-072_4fe4f372-10c2-42ca-bc69-d78a489672b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "52605-072", "generic_name": "Memantine hydrochloride", "labeler_name": "POLYGEN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA210587", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}