Primidone

Orange BookUNIISPLATC N03AA03

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN03AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
8280495300
100 TABLET in 1 BOTTLE, PLASTIC (82804-953-00)
ndc11
8280495311
1000 TABLET in 1 BOTTLE, PLASTIC (82804-953-11)
ndc11
8280495330
30 TABLET in 1 BOTTLE, PLASTIC (82804-953-30)
ndc11
8280495355
500 TABLET in 1 BOTTLE, PLASTIC (82804-953-55)
ndc11
8280495360
60 TABLET in 1 BOTTLE, PLASTIC (82804-953-60)
ndc11
8280495372
120 TABLET in 1 BOTTLE, PLASTIC (82804-953-72)
ndc11
8280495390
90 TABLET in 1 BOTTLE, PLASTIC (82804-953-90)

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": "82804-953_db761e34-8573-4f96-872c-e851b3004e5e",
  "productndc": "82804-953",
  "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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