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United States · US · US:59212-680_e3848741-066e-4ee2-bf13-0b4c1d32b3c2

Zonegran

Orange BookUNIISPLATC N03AX15

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

Identification

ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeN03AX15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5921268010
    100 CAPSULE in 1 BOTTLE (59212-680-10)

Annotations

UNII (FDA Substance ID)
459384H98V
ZONISAMIDE
RxCUI 39998
Orange Book
N020789
ABAB
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": {
    "d12de43e-3ac3-4335-bc85-70d7366a91eb": {
      "match": "brand_token",
      "title": "ZONEGRAN (ZONISAMIDE) CAPSULE [ADVANZ PHARMA (US) CORP.]",
      "spl_version": "12",
      "published_date": "2025-10-03"
    }
  },
  "productid": "59212-680_e3848741-066e-4ee2-bf13-0b4c1d32b3c2",
  "productndc": "59212-680",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "020789",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Aug 22, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Aug 22, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZONISAMIDE",
  "proprietary_name": "Zonegran",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020789",
  "marketing_category": "NDA",
  "nonproprietary_name": "Zonisamide",
  "start_marketing_date": "20000327",
  "active_numerator_strength": "100"
}

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