Mysoline

Orange BookUNIIATC N03AA03

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

Identification

ManufacturerBausch Health US, LLC

CountryUS (United States)

ATC codeN03AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6649069110
100 TABLET in 1 BOTTLE (66490-691-10)

Annotations

UNII (FDA Substance ID)

13AFD7670Q

PRIMIDONE

RxCUI 8691

Orange Book

N009170

ABAB

Raw payload (JSON)

{
  "unii": {
    "unii": "13AFD7670Q",
    "rxcui": "8691",
    "inchikey": "DQMZLTXERSFNPB-UHFFFAOYSA-N",
    "display_name": "PRIMIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "66490-691_9d9f03b1-4eb4-4ba5-a357-600e368802c6",
  "productndc": "66490-691",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "009170",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRIMIDONE",
  "proprietary_name": "Mysoline",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA009170",
  "marketing_category": "NDA",
  "nonproprietary_name": "Primidone",
  "start_marketing_date": "20090624",
  "active_numerator_strength": "250"
}

Related drugs

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