memantine hydrochloride

Generic: memantine hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-451
Product ID 46708-451_3d66d5be-d570-4041-82bf-6b6f4eef9ed8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200891
Listing Expiration 2026-12-31
Marketing Start 2015-10-13

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 46708451
Hyphenated Format 46708-451

Supplemental Identifiers

RxCUI
996561 996571
UPC
0346708452605 0346708451608
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 ANDA200891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 CARTON (46708-451-10)
  • 20 TABLET, COATED in 1 BOTTLE (46708-451-20)
  • 30 TABLET, COATED in 1 BOTTLE (46708-451-30)
  • 100 TABLET, COATED in 1 BOTTLE (46708-451-31)
  • 3000 TABLET, COATED in 1 BOTTLE (46708-451-42)
  • 60 TABLET, COATED in 1 BOTTLE (46708-451-60)
  • 1000 TABLET, COATED in 1 BOTTLE (46708-451-91)
source: ndc

Packages (7)

46708-451-10 100 TABLET, COATED in 1 CARTON (46708-451-10) 46708-451-20 20 TABLET, COATED in 1 BOTTLE (46708-451-20) 46708-451-30 30 TABLET, COATED in 1 BOTTLE (46708-451-30) 46708-451-31 100 TABLET, COATED in 1 BOTTLE (46708-451-31) 46708-451-42 3000 TABLET, COATED in 1 BOTTLE (46708-451-42) 46708-451-60 60 TABLET, COATED in 1 BOTTLE (46708-451-60) 46708-451-91 1000 TABLET, COATED in 1 BOTTLE (46708-451-91)

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": "3d66d5be-d570-4041-82bf-6b6f4eef9ed8", "openfda": {"upc": ["0346708452605", "0346708451608"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["b86c0f6e-480b-40e7-aa4d-21bd0659101d"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 CARTON (46708-451-10)", "package_ndc": "46708-451-10", "marketing_start_date": "20151013"}, {"sample": false, "description": "20 TABLET, COATED in 1 BOTTLE (46708-451-20)", "package_ndc": "46708-451-20", "marketing_start_date": "20151013"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (46708-451-30)", "package_ndc": "46708-451-30", "marketing_start_date": "20151013"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (46708-451-31)", "package_ndc": "46708-451-31", "marketing_start_date": "20151013"}, {"sample": false, "description": "3000 TABLET, COATED in 1 BOTTLE (46708-451-42)", "package_ndc": "46708-451-42", "marketing_start_date": "20151013"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (46708-451-60)", "package_ndc": "46708-451-60", "marketing_start_date": "20151013"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (46708-451-91)", "package_ndc": "46708-451-91", "marketing_start_date": "20151013"}], "brand_name": "Memantine Hydrochloride", "product_id": "46708-451_3d66d5be-d570-4041-82bf-6b6f4eef9ed8", "dosage_form": "TABLET, COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "46708-451", "generic_name": "memantine hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA200891", "marketing_category": "ANDA", "marketing_start_date": "20151013", "listing_expiration_date": "20261231"}