memantine hydrochloride

Generic: memantine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 21 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-854
Product ID 16571-854_4ece2bda-d26f-494f-93df-bc53c494caf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206032
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

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 16571854
Hyphenated Format 16571-854

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
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 (source: ndc)
Application Number ANDA206032 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 21 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-854-03)
source: ndc

Packages (1)

16571-854-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-854-03)

Ingredients (1)

memantine hydrochloride (21 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": "4ece2bda-d26f-494f-93df-bc53c494caf9", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["a282fbed-8304-458e-a0e9-5eaccc95339b"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-854-03)", "package_ndc": "16571-854-03", "marketing_start_date": "20250601"}], "brand_name": "Memantine Hydrochloride", "product_id": "16571-854_4ece2bda-d26f-494f-93df-bc53c494caf9", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "16571-854", "generic_name": "memantine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "21 mg/1"}], "application_number": "ANDA206032", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}