Memantine Hydrochloride

Orange BookUNIISPLATC N06DX01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN06DX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6586265303
3 BLISTER PACK in 1 CARTON (65862-653-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10)
ndc11
6586265360
60 TABLET, FILM COATED in 1 BOTTLE (65862-653-60)
ndc11
6586265378
10 BLISTER PACK in 1 CARTON (65862-653-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10)
ndc11
6586265399
1000 TABLET, FILM COATED in 1 BOTTLE (65862-653-99)

Annotations

UNII (FDA Substance ID)

JY0WD0UA60

MEMANTINE HYDROCHLORIDE

RxCUI 236685

Orange Book

A203175

ABAB

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": "65862-653_12f3b127-625b-4c19-99f5-54f0ddc5cdc0",
  "productndc": "65862-653",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203175",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Oct 13, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Oct 13, 2015"
      }
    ],
    "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": "ANDA203175",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Memantine Hydrochloride",
  "start_marketing_date": "20151013",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06DX01.

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