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United States · US · US:0456-1221_00cae29c-d07a-484b-b279-be68f15c5e73

Namzaric

Orange BookUNIISPLATC N06DA

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeN06DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0456122130
    30 CAPSULE in 1 BOTTLE (0456-1221-30)

Annotations

UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
N206439
ABABABAB
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": {
    "90fedc32-19e5-480c-afc6-f35a5cf4b9aa": {
      "match": "brand_token",
      "title": "NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) CAPSULE NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE) KIT [ALLERGAN, INC.]",
      "spl_version": "23",
      "published_date": "2026-05-06"
    }
  },
  "productid": "0456-1221_00cae29c-d07a-484b-b279-be68f15c5e73",
  "productndc": "0456-1221",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206439",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;14MG",
        "product_no": "001",
        "approval_date": "Dec 23, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;28MG",
        "product_no": "002",
        "approval_date": "Dec 23, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;7MG",
        "product_no": "003",
        "approval_date": "Jul 18, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;21MG",
        "product_no": "004",
        "approval_date": "Jul 18, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE",
  "proprietary_name": "Namzaric",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA206439",
  "marketing_category": "NDA",
  "nonproprietary_name": "memantine hydrochloride and donepezil hydrochloride",
  "start_marketing_date": "20160718",
  "active_numerator_strength": "10; 21"
}

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