Primidone

Orange BookUNIISPLATC N03AA03

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN03AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7161059060
90 TABLET in 1 BOTTLE, PLASTIC (71610-590-60)
ndc11
7161059080
180 TABLET in 1 BOTTLE, PLASTIC (71610-590-80)
ndc11
7161059092
270 TABLET in 1 BOTTLE, PLASTIC (71610-590-92)
ndc11
7161059094
360 TABLET in 1 BOTTLE, PLASTIC (71610-590-94)

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": "71610-590_a13f7ad0-b9c2-43c3-88cf-f232eacb2140",
  "productndc": "71610-590",
  "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": "50"
}

Related drugs

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