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United States · US · US:62332-076_9792a0a6-a48e-4998-9f5a-c9eaa144edea

Memantine Hydrochloride

Orange BookUNIISPLATC N06DX01

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06DX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6233207610
    100 TABLET, COATED in 1 CARTON (62332-076-10)
  • ndc11
    6233207620
    20 TABLET, COATED in 1 BOTTLE (62332-076-20)
  • ndc11
    6233207630
    30 TABLET, COATED in 1 BOTTLE (62332-076-30)
  • ndc11
    6233207631
    100 TABLET, COATED in 1 BOTTLE (62332-076-31)
  • ndc11
    6233207642
    3000 TABLET, COATED in 1 BOTTLE (62332-076-42)
  • ndc11
    6233207660
    60 TABLET, COATED in 1 BOTTLE (62332-076-60)
  • ndc11
    6233207671
    500 TABLET, COATED in 1 BOTTLE (62332-076-71)

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": "62332-076_9792a0a6-a48e-4998-9f5a-c9eaa144edea",
  "productndc": "62332-076",
  "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"
}

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