memantine hydrochloride

Generic: memantine hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler lannett company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1221
Product ID 0527-1221_01ef9666-220d-4b84-96d5-db7792923329
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207236
Listing Expiration 2026-12-31
Marketing Start 2016-11-10

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 05271221
Hyphenated Format 0527-1221

Supplemental Identifiers

RxCUI
996561 996571
UPC
0305271221063 0305271222060
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 ANDA207236 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE, PLASTIC (0527-1221-05)
  • 60 TABLET in 1 BOTTLE, PLASTIC (0527-1221-06)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0527-1221-10)
source: ndc

Packages (3)

0527-1221-05 500 TABLET in 1 BOTTLE, PLASTIC (0527-1221-05) 0527-1221-06 60 TABLET in 1 BOTTLE, PLASTIC (0527-1221-06) 0527-1221-10 1000 TABLET in 1 BOTTLE, PLASTIC (0527-1221-10)

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": "01ef9666-220d-4b84-96d5-db7792923329", "openfda": {"upc": ["0305271221063", "0305271222060"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["88b7952b-b58a-495e-aa19-d3392d2e2759"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0527-1221-05)", "package_ndc": "0527-1221-05", "marketing_start_date": "20161110"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (0527-1221-06)", "package_ndc": "0527-1221-06", "marketing_start_date": "20161110"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0527-1221-10)", "package_ndc": "0527-1221-10", "marketing_start_date": "20161110"}], "brand_name": "Memantine Hydrochloride", "product_id": "0527-1221_01ef9666-220d-4b84-96d5-db7792923329", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "0527-1221", "generic_name": "Memantine Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA207236", "marketing_category": "ANDA", "marketing_start_date": "20161110", "listing_expiration_date": "20261231"}