Primidone

Orange BookUNIISPLATC N03AA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOxford Pharmaceuticals, LLC

CountryUS (United States)

ATC codeN03AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6958468510
100 TABLET in 1 BOTTLE, PLASTIC (69584-685-10)
ndc11
6958468550
500 TABLET in 1 BOTTLE (69584-685-50)

Annotations

UNII (FDA Substance ID)

13AFD7670Q

PRIMIDONE

RxCUI 8691

Orange Book

A040586

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": "69584-685_86b0848d-c247-4e50-bc01-dce7dc157605",
  "productndc": "69584-685",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040586",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Feb 24, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Feb 24, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRIMIDONE",
  "proprietary_name": "Primidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040586",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Primidone",
  "start_marketing_date": "20210222",
  "active_numerator_strength": "250"
}

Related drugs

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