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United States · US · US:70771-1120_71694aca-1930-42bc-8322-6470fd047953

Memantine Hydrochloride

Orange BookUNIISPLATC N06DX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN06DX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7077111200
    1000 TABLET, FILM COATED in 1 BOTTLE (70771-1120-0)
  • ndc11
    7077111201
    100 TABLET, FILM COATED in 1 BOTTLE (70771-1120-1)
  • ndc11
    7077111204
    1000 BLISTER PACK in 1 CARTON (70771-1120-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70771-1120-2)
  • ndc11
    7077111205
    500 TABLET, FILM COATED in 1 BOTTLE (70771-1120-5)
  • ndc11
    7077111206
    60 TABLET, FILM COATED in 1 BOTTLE (70771-1120-6)

Annotations

UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A090961
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": "70771-1120_71694aca-1930-42bc-8322-6470fd047953",
  "productndc": "70771-1120",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090961",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 10, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 10, 2017"
      }
    ],
    "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": "ANDA090961",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Memantine Hydrochloride",
  "start_marketing_date": "20170928",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06DX01.

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