memantine hydrochloride

Generic: memantine hydrochloride

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler slate run pharmaceuticals, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 28 mg/1

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-057
Product ID 70436-057_44e0a1f7-89be-2a98-e063-6394a90af180
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211100
Listing Expiration 2026-12-31
Marketing Start 2021-11-15

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 70436057
Hyphenated Format 70436-057

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
UPC
0370436054046 0370436057061 0370436057047 0370436055043 0370436056040 0370436055067
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 ANDA211100 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 28 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-04)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-06)
source: ndc

Packages (2)

70436-057-04 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-04) 70436-057-06 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-06)

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": "44e0a1f7-89be-2a98-e063-6394a90af180", "openfda": {"upc": ["0370436054046", "0370436057061", "0370436057047", "0370436055043", "0370436056040", "0370436055067"], "unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["a74050c4-5a37-4fa1-85d9-85831525cfeb"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-04)", "package_ndc": "70436-057-04", "marketing_start_date": "20211115"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-06)", "package_ndc": "70436-057-06", "marketing_start_date": "20211115"}], "brand_name": "Memantine Hydrochloride", "product_id": "70436-057_44e0a1f7-89be-2a98-e063-6394a90af180", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "70436-057", "generic_name": "memantine hydrochloride", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "28 mg/1"}], "application_number": "ANDA211100", "marketing_category": "ANDA", "marketing_start_date": "20211115", "listing_expiration_date": "20261231"}