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
4670845110
100 TABLET, COATED in 1 CARTON (46708-451-10)
ndc11
4670845120
20 TABLET, COATED in 1 BOTTLE (46708-451-20)
ndc11
4670845130
30 TABLET, COATED in 1 BOTTLE (46708-451-30)
ndc11
4670845131
100 TABLET, COATED in 1 BOTTLE (46708-451-31)
ndc11
4670845142
3000 TABLET, COATED in 1 BOTTLE (46708-451-42)
ndc11
4670845160
60 TABLET, COATED in 1 BOTTLE (46708-451-60)
ndc11
4670845191
1000 TABLET, COATED in 1 BOTTLE (46708-451-91)

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": "46708-451_3d66d5be-d570-4041-82bf-6b6f4eef9ed8",
  "productndc": "46708-451",
  "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": "5"
}

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