memantine hydrochloride

Generic: memantine hydrochloride

Labeler: dr. reddys laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler dr. reddys laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
Dr. Reddys Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-597
Product ID 55111-597_998c5d15-8b47-fe20-82c5-98897caf80eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090048
Listing Expiration 2026-12-31
Marketing Start 2015-07-11

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 55111597
Hyphenated Format 55111-597

Supplemental Identifiers

RxCUI
996561 996571
UPC
0355111596608
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 ANDA090048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (55111-597-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-597-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-597-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (55111-597-60)
  • 10 BLISTER PACK in 1 CARTON (55111-597-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (55111-597-79) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (6)

55111-597-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-597-01) 55111-597-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-597-05) 55111-597-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-597-30) 55111-597-60 60 TABLET, FILM COATED in 1 BOTTLE (55111-597-60) 55111-597-78 10 BLISTER PACK in 1 CARTON (55111-597-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK 55111-597-79 1 BLISTER PACK in 1 CARTON (55111-597-79) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

memantine hydrochloride (10 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": "998c5d15-8b47-fe20-82c5-98897caf80eb", "openfda": {"upc": ["0355111596608"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["a71e2482-5266-d03e-8b36-862afe78c9a4"], "manufacturer_name": ["Dr. Reddys Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (55111-597-01)", "package_ndc": "55111-597-01", "marketing_start_date": "20150711"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-597-05)", "package_ndc": "55111-597-05", "marketing_start_date": "20150711"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-597-30)", "package_ndc": "55111-597-30", "marketing_start_date": "20150711"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (55111-597-60)", "package_ndc": "55111-597-60", "marketing_start_date": "20150711"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-597-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55111-597-78", "marketing_start_date": "20150711"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55111-597-79)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55111-597-79", "marketing_start_date": "20150711"}], "brand_name": "Memantine Hydrochloride", "product_id": "55111-597_998c5d15-8b47-fe20-82c5-98897caf80eb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "55111-597", "generic_name": "Memantine Hydrochloride", "labeler_name": "Dr. Reddys Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090048", "marketing_category": "ANDA", "marketing_start_date": "20150711", "listing_expiration_date": "20261231"}