Memantine Hydrochloride

Orange BookUNIISPLATC N06DX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeN06DX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1657185503
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-855-03)
ndc11
1657185509
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-855-09)

Annotations

UNII (FDA Substance ID)

JY0WD0UA60

MEMANTINE HYDROCHLORIDE

RxCUI 236685

Orange Book

A206032

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "JY0WD0UA60",
    "rxcui": "236685",
    "inchikey": "LDDHMLJTFXJGPI-UHFFFAOYSA-N",
    "display_name": "MEMANTINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "afc07196-be28-4521-afc0-d4aa5b6fd46d": {
      "match": "brand_token",
      "title": "MEMANTINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-22"
    }
  },
  "productid": "16571-855_4ece2bda-d26f-494f-93df-bc53c494caf9",
  "productndc": "16571-855",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206032",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "21MG",
        "product_no": "003",
        "approval_date": "Sep 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "28MG",
        "product_no": "004",
        "approval_date": "Sep 28, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEMANTINE HYDROCHLORIDE",
  "proprietary_name": "Memantine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206032",
  "marketing_category": "ANDA",
  "nonproprietary_name": "memantine",
  "start_marketing_date": "20250601",
  "active_numerator_strength": "28"
}

Related drugs

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