ZONISADE

Orange BookUNIISPLATC N03AX15

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN03AX15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5265280011
1 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

459384H98V

ZONISAMIDE

RxCUI 39998

Orange Book

N214273

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": {
    "ac16fa15-32e9-4f92-8bc6-d8d41ae002c6": {
      "match": "brand_token",
      "title": "ZONISADE (ZONISAMIDE) SUSPENSION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-09-29"
    }
  },
  "productid": "52652-8001_063fd04f-90bf-4b1f-99fe-4e2cdb5b1eea",
  "productndc": "52652-8001",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "214273",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 15, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZONISAMIDE",
  "proprietary_name": "ZONISADE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA214273",
  "marketing_category": "NDA",
  "nonproprietary_name": "ZONISAMIDE",
  "start_marketing_date": "20220715",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AX15.

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