memantine hydrochloride

Generic: memantine hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-297
Product ID 33342-297_672222e3-12b9-488f-a5ee-c47736d65cce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202840
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 33342297
Hyphenated Format 33342-297

Supplemental Identifiers

RxCUI
996561 996571
UPC
0333342297099 0333342298096 0333342298157
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 ANDA202840 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (33342-297-09)
  • 10 BLISTER PACK in 1 CARTON (33342-297-12) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (33342-297-15)
source: ndc

Packages (3)

33342-297-09 60 TABLET in 1 BOTTLE (33342-297-09) 33342-297-12 10 BLISTER PACK in 1 CARTON (33342-297-12) / 10 TABLET in 1 BLISTER PACK 33342-297-15 500 TABLET in 1 BOTTLE (33342-297-15)

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": "672222e3-12b9-488f-a5ee-c47736d65cce", "openfda": {"upc": ["0333342297099", "0333342298096", "0333342298157"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["989fa756-7d70-4ea7-bb5e-f4395e48589d"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (33342-297-09)", "package_ndc": "33342-297-09", "marketing_start_date": "20151013"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-297-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-297-12", "marketing_start_date": "20151013"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-297-15)", "package_ndc": "33342-297-15", "marketing_start_date": "20151013"}], "brand_name": "Memantine Hydrochloride", "product_id": "33342-297_672222e3-12b9-488f-a5ee-c47736d65cce", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "33342-297", "generic_name": "Memantine Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202840", "marketing_category": "ANDA", "marketing_start_date": "20151013", "listing_expiration_date": "20261231"}