Primidone

Orange BookUNIISPLATC N03AA03

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeN03AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5511147701
100 TABLET in 1 BOTTLE (55111-477-01)
ndc11
5511147705
500 TABLET in 1 BOTTLE (55111-477-05)
ndc11
5511147730
30 TABLET in 1 BOTTLE (55111-477-30)
ndc11
5511147760
60 TABLET in 1 BOTTLE (55111-477-60)
ndc11
5511147778
10 BLISTER PACK in 1 CARTON (55111-477-78) / 10 TABLET in 1 BLISTER PACK (55111-477-79)

Annotations

UNII (FDA Substance ID)

13AFD7670Q

PRIMIDONE

RxCUI 8691

Orange Book

A040862

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": "55111-477_6f5c36d3-3f99-803c-5be6-66b2e1058946",
  "productndc": "55111-477",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040862",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Oct 3, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Oct 3, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRIMIDONE",
  "proprietary_name": "Primidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040862",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Primidone",
  "start_marketing_date": "20081003",
  "active_numerator_strength": "50"
}

Related drugs

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