memantine hydrochloride

Generic: memantine hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-171
Product ID 29300-171_16cd3370-8ddc-4dbb-82b3-98e128fb3482
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200022
Listing Expiration 2026-12-31
Marketing Start 2015-11-01

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 29300171
Hyphenated Format 29300-171

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 ANDA200022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-171-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-171-16)
source: ndc

Packages (2)

29300-171-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-171-05) 29300-171-16 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-171-16)

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": "16cd3370-8ddc-4dbb-82b3-98e128fb3482", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-171-05)", "package_ndc": "29300-171-05", "marketing_start_date": "20151101"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-171-16)", "package_ndc": "29300-171-16", "marketing_start_date": "20151101"}], "brand_name": "Memantine Hydrochloride", "product_id": "29300-171_16cd3370-8ddc-4dbb-82b3-98e128fb3482", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "29300-171", "generic_name": "memantine hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA200022", "marketing_category": "ANDA", "marketing_start_date": "20151101", "listing_expiration_date": "20261231"}