phenytoin sodium

Orange BookUNIISPLATC N03AB02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN03AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6275629908
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-08)
ndc11
6275629913
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-13)
ndc11
6275629983
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-83)
ndc11
6275629988
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-88)

Annotations

UNII (FDA Substance ID)

4182431BJH

PHENYTOIN SODIUM

RxCUI 71227

Orange Book

A040731

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": "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": "62756-299_c89dfc75-606c-4a4e-9d2b-d907b492a837",
  "productndc": "62756-299",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "040731",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG EXTENDED",
        "product_no": "001",
        "approval_date": "Jun 30, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG EXTENDED",
        "product_no": "002",
        "approval_date": "Jun 30, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYTOIN SODIUM",
  "proprietary_name": "phenytoin sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040731",
  "marketing_category": "ANDA",
  "nonproprietary_name": "phenytoin sodium",
  "start_marketing_date": "20080630",
  "active_numerator_strength": "200"
}

Related drugs

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