memantine hydrochloride

Generic: memantine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

memantine hydrochloride 28 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6735
Product ID 0904-6735_64e26acf-3799-4ad1-b91f-cf5766e5ada9
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 09046735
Hyphenated Format 0904-6735

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
UNII
JY0WD0UA60

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
  • 100 BLISTER PACK in 1 CARTON (0904-6735-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6735-61 100 BLISTER PACK in 1 CARTON (0904-6735-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

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": "64e26acf-3799-4ad1-b91f-cf5766e5ada9", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["f6ce7cca-d245-44f2-986c-2a8d85dbb5fb"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6735-61)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6735-61", "marketing_start_date": "20180220"}], "brand_name": "memantine hydrochloride", "product_id": "0904-6735_64e26acf-3799-4ad1-b91f-cf5766e5ada9", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "0904-6735", "generic_name": "memantine hydrochloride", "labeler_name": "Major Pharmaceuticals", "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"}