memantine hydrochloride

Generic: memantine hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 28 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-249
Product ID 68180-249_2eba035e-38ce-479d-8dc8-0bfdd2bffbcf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206028
Listing Expiration 2027-12-31
Marketing Start 2018-02-20

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 68180249
Hyphenated Format 68180-249

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
UPC
0368180247067 0368180249061 0368180246060
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 ANDA206028 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 28 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-06)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-09)
source: ndc

Packages (2)

68180-249-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-06) 68180-249-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-09)

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": "2eba035e-38ce-479d-8dc8-0bfdd2bffbcf", "openfda": {"upc": ["0368180247067", "0368180249061", "0368180246060"], "unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["24290655-47f3-4042-a977-a832c5161d2c"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-06)", "package_ndc": "68180-249-06", "marketing_start_date": "20180220"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68180-249-09)", "package_ndc": "68180-249-09", "marketing_start_date": "20180220"}], "brand_name": "memantine hydrochloride", "product_id": "68180-249_2eba035e-38ce-479d-8dc8-0bfdd2bffbcf", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "68180-249", "generic_name": "memantine hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "28 mg/1"}], "application_number": "ANDA206028", "marketing_category": "ANDA", "marketing_start_date": "20180220", "listing_expiration_date": "20271231"}