memantine hydrochloride

Generic: memantine hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler aurobindo pharma limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 28 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-407
Product ID 59651-407_7a208302-90f3-45d0-94fc-9fb38591c543
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214651
Listing Expiration 2026-12-31
Marketing Start 2021-08-09

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 59651407
Hyphenated Format 59651-407

Supplemental Identifiers

RxCUI
996594 996603 996609 996615 996624
UPC
0359651406304 0359651404300
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 ANDA214651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 28 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-30)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-90)
source: ndc

Packages (2)

59651-407-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-30) 59651-407-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-90)

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": "7a208302-90f3-45d0-94fc-9fb38591c543", "openfda": {"upc": ["0359651406304", "0359651404300"], "unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615", "996624"], "spl_set_id": ["2b2dcd54-47e0-494b-85d2-c28c3adbe737"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-30)", "package_ndc": "59651-407-30", "marketing_start_date": "20210809"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-90)", "package_ndc": "59651-407-90", "marketing_start_date": "20210809"}], "brand_name": "MEMANTINE HYDROCHLORIDE", "product_id": "59651-407_7a208302-90f3-45d0-94fc-9fb38591c543", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "59651-407", "generic_name": "MEMANTINE HYDROCHLORIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEMANTINE HYDROCHLORIDE", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "28 mg/1"}], "application_number": "ANDA214651", "marketing_category": "ANDA", "marketing_start_date": "20210809", "listing_expiration_date": "20261231"}