Primidone

Orange BookUNIISPLATC N03AA03

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

Identification

ManufacturerAdvagen Pharma Limited

CountryUS (United States)

ATC codeN03AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7288804601
100 TABLET in 1 BOTTLE (72888-046-01)
ndc11
7288804605
500 TABLET in 1 BOTTLE (72888-046-05)

Annotations

UNII (FDA Substance ID)

13AFD7670Q

PRIMIDONE

RxCUI 8691

Orange Book

A214896

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": "72888-046_48453b30-812c-76c6-e063-6394a90ad9a0",
  "productndc": "72888-046",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214896",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Jun 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "125MG",
        "product_no": "003",
        "approval_date": "Dec 28, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRIMIDONE",
  "proprietary_name": "Primidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214896",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Primidone",
  "start_marketing_date": "20220628",
  "active_numerator_strength": "250"
}

Related drugs

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