memantine hydrochloride

Generic: memantine hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 28 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8264
Product ID 0615-8264_194f162d-30bc-420f-85ae-fca98d00705a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206028
Marketing Start 2018-02-20
Marketing End 2026-07-31

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 06158264
Hyphenated Format 0615-8264

Supplemental Identifiers

RxCUI
996609
UNII
JY0WD0UA60

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 ANDA206028 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 28 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8264-39)
source: ndc

Packages (1)

0615-8264-39 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8264-39)

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": "194f162d-30bc-420f-85ae-fca98d00705a", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996609"], "spl_set_id": ["e2a371f6-8bfe-4049-b9ca-0ab3d726379e"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8264-39)", "package_ndc": "0615-8264-39", "marketing_end_date": "20260731", "marketing_start_date": "20190109"}], "brand_name": "memantine hydrochloride", "product_id": "0615-8264_194f162d-30bc-420f-85ae-fca98d00705a", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "0615-8264", "generic_name": "memantine hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "28 mg/1"}], "application_number": "ANDA206028", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20180220"}