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United States · US · US:71872-7079_0aaca355-f97c-6453-e063-6394a90a07bc

Phenytoin Sodium

Orange BookUNIISPLATC N03AB02

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

Identification

ManufacturerMedical Purchasing Solutions, LLC
CountryUS (United States)
ATC codeN03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7187270791
    1 VIAL in 1 BAG (71872-7079-1) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A084307
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4182431BJH",
    "rxcui": "71227",
    "inchikey": "FJPYVLNWWICYDW-UHFFFAOYSA-M",
    "display_name": "PHENYTOIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "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": "71872-7079_0aaca355-f97c-6453-e063-6394a90a07bc",
  "productndc": "71872-7079",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "084307",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/ML",
        "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 SODIUM",
  "proprietary_name": "Phenytoin Sodium",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA084307",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phenytoin Sodium",
  "start_marketing_date": "19750716",
  "active_numerator_strength": "50"
}

Related drugs

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