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United States · US · US:80005-118_1f77f842-e0b6-4659-beee-0bb01da839e3

Primidone

Orange BookUNIISPLATC N03AA03

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

Identification

ManufacturerCarnegie Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8000511811
    100 TABLET in 1 BOTTLE (80005-118-11)
  • ndc11
    8000511814
    500 TABLET in 1 BOTTLE (80005-118-14)
  • ndc11
    8000511815
    1000 TABLET in 1 BOTTLE (80005-118-15)

Annotations

UNII (FDA Substance ID)
13AFD7670Q
PRIMIDONE
RxCUI 8691
Orange Book
A218366
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "13AFD7670Q",
    "rxcui": "8691",
    "inchikey": "DQMZLTXERSFNPB-UHFFFAOYSA-N",
    "display_name": "PRIMIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e7a50a67-9653-463e-8c85-315b53f460c8": {
      "match": "brand_token",
      "title": "PRIMIDONE TABLET [AVKARE]",
      "spl_version": "11",
      "published_date": "2026-05-15"
    }
  },
  "productid": "80005-118_1f77f842-e0b6-4659-beee-0bb01da839e3",
  "productndc": "80005-118",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218366",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jan 23, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Jan 23, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRIMIDONE",
  "proprietary_name": "Primidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218366",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Primidone",
  "start_marketing_date": "20240501",
  "active_numerator_strength": "250"
}

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