memantine hydrochloride

Generic: memantine hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

memantine hydrochloride 5 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3870
Product ID 0591-3870_985e1190-b8a0-4775-9a20-ad1924b14fb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021487
Marketing Start 2015-04-01
Marketing End 2028-07-31

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 05913870
Hyphenated Format 0591-3870

Supplemental Identifiers

RxCUI
996561 996571 996572
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 NDA021487 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0591-3870-44) / 10 TABLET in 1 BLISTER PACK (0591-3870-45)
  • 60 TABLET in 1 BOTTLE (0591-3870-60)
source: ndc

Packages (2)

0591-3870-44 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0591-3870-44) / 10 TABLET in 1 BLISTER PACK (0591-3870-45) 0591-3870-60 60 TABLET in 1 BOTTLE (0591-3870-60)

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": "985e1190-b8a0-4775-9a20-ad1924b14fb2", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571", "996572"], "spl_set_id": ["72973b46-f307-4a9e-8fb1-ad2cbccfd736"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (0591-3870-44)  / 10 TABLET in 1 BLISTER PACK (0591-3870-45)", "package_ndc": "0591-3870-44", "marketing_end_date": "20270930", "marketing_start_date": "20150401"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0591-3870-60)", "package_ndc": "0591-3870-60", "marketing_end_date": "20280731", "marketing_start_date": "20150401"}], "brand_name": "memantine hydrochloride", "product_id": "0591-3870_985e1190-b8a0-4775-9a20-ad1924b14fb2", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "0591-3870", "generic_name": "memantine hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA021487", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20280731", "marketing_start_date": "20150401"}