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 CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 28 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-222
Product ID 33342-222_1c695653-b7dd-40af-b5eb-a6e3ecbab14d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206310
Listing Expiration 2026-12-31
Marketing Start 2025-08-28

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 33342222
Hyphenated Format 33342-222

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
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 ANDA206310 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 28 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07)
  • 10 BLISTER PACK in 1 CARTON (33342-222-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

33342-222-07 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07) 33342-222-12 10 BLISTER PACK in 1 CARTON (33342-222-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

memantine hydrochloride (28 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": "1c695653-b7dd-40af-b5eb-a6e3ecbab14d", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["62e32b0b-1eb2-424d-bfd2-d27ef27d35f3"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07)", "package_ndc": "33342-222-07", "marketing_start_date": "20250828"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-222-12)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-222-12", "marketing_start_date": "20250828"}], "brand_name": "Memantine hydrochloride", "product_id": "33342-222_1c695653-b7dd-40af-b5eb-a6e3ecbab14d", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "33342-222", "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": "28 mg/1"}], "application_number": "ANDA206310", "marketing_category": "ANDA", "marketing_start_date": "20250828", "listing_expiration_date": "20261231"}