memantine hydrochloride

Generic: memantine hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

memantine hydrochloride 21 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1323
Product ID 70771-1323_900483ef-de89-464c-a324-8bfaa8f137a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203293
Listing Expiration 2026-12-31
Marketing Start 2018-04-08

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 707711323
Hyphenated Format 70771-1323

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
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 ANDA203293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 21 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1323-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1323-2)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-9)
source: ndc

Packages (3)

70771-1323-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-3) 70771-1323-4 10 BLISTER PACK in 1 CARTON (70771-1323-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1323-2) 70771-1323-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-9)

Ingredients (1)

memantine hydrochloride (21 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": "900483ef-de89-464c-a324-8bfaa8f137a6", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["ec825bef-2313-45c2-8858-b43197680155"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-3)", "package_ndc": "70771-1323-3", "marketing_start_date": "20180408"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1323-4)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1323-2)", "package_ndc": "70771-1323-4", "marketing_start_date": "20180408"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-9)", "package_ndc": "70771-1323-9", "marketing_start_date": "20180408"}], "brand_name": "Memantine hydrochloride", "product_id": "70771-1323_900483ef-de89-464c-a324-8bfaa8f137a6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "70771-1323", "generic_name": "Memantine hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "21 mg/1"}], "application_number": "ANDA203293", "marketing_category": "ANDA", "marketing_start_date": "20180408", "listing_expiration_date": "20261231"}