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United States · US · US:0071-0007_80f0cff3-357e-4328-860e-bbd525d80e6b

Dilantin Infatabs

Orange BookUNIISPLATC N03AB02

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

Identification

ManufacturerParke-Davis Div of Pfizer Inc
CountryUS (United States)
ATC codeN03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0071000724
    100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24)

Annotations

UNII (FDA Substance ID)
6158TKW0C5
PHENYTOIN
RxCUI 8183
Orange Book
A084427
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": {
    "ca119a89-2394-4d34-8078-cd1fa4e8e2f1": {
      "match": "brand_token",
      "title": "DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC]",
      "spl_version": "58",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0071-0007_80f0cff3-357e-4328-860e-bbd525d80e6b",
  "productndc": "0071-0007",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "084427",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYTOIN",
  "proprietary_name": "Dilantin Infatabs",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA084427",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phenytoin",
  "start_marketing_date": "19790226",
  "active_numerator_strength": "50"
}

Related drugs

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