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United States · US · US:31722-807_eabf0e61-425e-9c9f-e053-2a95a90ade8e

memantine hydrochloride

Orange BookUNIISPLATC N06DX01

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

Identification

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

Packs · 3

  • ndc11
    3172280702
    200 TABLET in 1 BOTTLE (31722-807-02)
  • ndc11
    3172280732
    10 BLISTER PACK in 1 CARTON (31722-807-32) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    3172280760
    60 TABLET in 1 BOTTLE (31722-807-60)

Annotations

UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A204389
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": "31722-807_eabf0e61-425e-9c9f-e053-2a95a90ade8e",
  "productndc": "31722-807",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204389",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 26, 2022"
      }
    ],
    "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": "ANDA204389",
  "marketing_category": "ANDA",
  "nonproprietary_name": "memantine hydrochloride",
  "start_marketing_date": "20220926",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N06DX01.

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