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United States · US · US:33342-313_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14

Memantine and Donepezil

Orange BookUNIISPLATC N06DA

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeN06DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3334231307
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-07)
  • ndc11
    3334231310
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-10)
  • ndc11
    3334231356
    10 BLISTER PACK in 1 CARTON (33342-313-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
A208672
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3O2T2PJ89D",
    "rxcui": "236559",
    "inchikey": "XWAIAVWHZJNZQQ-UHFFFAOYSA-N",
    "display_name": "DONEPEZIL 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": "33342-313_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14",
  "productndc": "33342-313",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208672",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;14MG",
        "product_no": "001",
        "approval_date": "Jul 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;28MG",
        "product_no": "002",
        "approval_date": "Jul 15, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE",
  "proprietary_name": "Memantine and Donepezil",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208672",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Memantine and Donepezil",
  "start_marketing_date": "20250715",
  "active_numerator_strength": "10; 28"
}

Related drugs

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