Zonisamide

Orange BookUNIISPLATC N03AX15

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

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC codeN03AX15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026881615
50 BLISTER PACK in 1 BOX (50268-816-15) / 1 CAPSULE in 1 BLISTER PACK (50268-816-11)

Annotations

UNII (FDA Substance ID)

459384H98V

ZONISAMIDE

RxCUI 39998

Orange Book

A077869

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "459384H98V",
    "rxcui": "39998",
    "inchikey": "UBQNRHZMVUUOMG-UHFFFAOYSA-N",
    "display_name": "ZONISAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "50bb1a0a-a66d-4a13-a456-a10c1b8c8e94": {
      "match": "brand_token",
      "title": "ZONISAMIDE CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50268-816_41ac7d6a-8113-6e97-e063-6394a90a088b",
  "productndc": "50268-816",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077869",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 31, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZONISAMIDE",
  "proprietary_name": "Zonisamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077869",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zonisamide",
  "start_marketing_date": "20140702",
  "active_numerator_strength": "100"
}

Related drugs

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