Memantine Hydrochloride

Orange BookUNIISPLATC N06DX01

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN06DX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
4670845210
100 TABLET, COATED in 1 CARTON (46708-452-10)
ndc11
4670845220
20 TABLET, COATED in 1 BOTTLE (46708-452-20)
ndc11
4670845230
30 TABLET, COATED in 1 BOTTLE (46708-452-30)
ndc11
4670845231
100 TABLET, COATED in 1 BOTTLE (46708-452-31)
ndc11
4670845242
3000 TABLET, COATED in 1 BOTTLE (46708-452-42)
ndc11
4670845260
60 TABLET, COATED in 1 BOTTLE (46708-452-60)
ndc11
4670845271
500 TABLET, COATED in 1 BOTTLE (46708-452-71)

Annotations

UNII (FDA Substance ID)

JY0WD0UA60

MEMANTINE HYDROCHLORIDE

RxCUI 236685

Orange Book

A200891

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": "46708-452_3d66d5be-d570-4041-82bf-6b6f4eef9ed8",
  "productndc": "46708-452",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "200891",
    "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": "ANDA200891",
  "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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