memantine hydrochloride

Generic: memantine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

memantine hydrochloride 2 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-943
Product ID 62135-943_499eab19-cf6f-dfcd-e063-6294a90acc1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204033
Listing Expiration 2027-12-31
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 62135943
Hyphenated Format 62135-943

Supplemental Identifiers

RxCUI
996740
UPC
0362135943370
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 ANDA204033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-943-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-943-05)
  • 240 mL in 1 BOTTLE (62135-943-37)
source: ndc

Packages (2)

62135-943-24 2 TRAY in 1 BOX (62135-943-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-943-05) 62135-943-37 240 mL in 1 BOTTLE (62135-943-37)

Ingredients (1)

memantine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Memantine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "499eab19-cf6f-dfcd-e063-6294a90acc1d", "openfda": {"upc": ["0362135943370"], "unii": ["JY0WD0UA60"], "rxcui": ["996740"], "spl_set_id": ["a7b76864-6de7-45f6-be5b-5ecfca811627"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-943-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-943-05)", "package_ndc": "62135-943-24", "marketing_start_date": "20250225"}, {"sample": false, "description": "240 mL in 1 BOTTLE (62135-943-37)", "package_ndc": "62135-943-37", "marketing_start_date": "20221027"}], "brand_name": "Memantine Hydrochloride", "product_id": "62135-943_499eab19-cf6f-dfcd-e063-6294a90acc1d", "dosage_form": "SOLUTION", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "62135-943", "generic_name": "Memantine Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA204033", "marketing_category": "ANDA", "marketing_start_date": "20151013", "listing_expiration_date": "20271231"}