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United States · US · US:0904-7199_066e29d5-dcad-4017-a345-085432105a41

Phenytoin

Orange BookUNIISPLATC N03AB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeN03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0904719907
    30 BLISTER PACK in 1 CARTON (0904-7199-07) / 1 TABLET, CHEWABLE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6158TKW0C5
PHENYTOIN
RxCUI 8183
Orange Book
A200565
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6158TKW0C5",
    "rxcui": "8183",
    "inchikey": "CXOFVDLJLONNDW-UHFFFAOYSA-N",
    "display_name": "PHENYTOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3580e6a8-f7c3-44a0-a1eb-2a84ae589d21": {
      "match": "brand_token",
      "title": "PHENYTOIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PRASCO LABORATORIES]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0904-7199_066e29d5-dcad-4017-a345-085432105a41",
  "productndc": "0904-7199",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "200565",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Apr 17, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYTOIN",
  "proprietary_name": "Phenytoin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200565",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phenytoin",
  "start_marketing_date": "20140417",
  "active_numerator_strength": "50"
}

Related drugs

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