Zonisamide

Orange BookUNIISPLATC N03AX15

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN03AX15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5965137801
100 CAPSULE in 1 BOTTLE (59651-378-01)
ndc11
5965137803
30 CAPSULE in 1 BOTTLE (59651-378-03)
ndc11
5965137805
500 CAPSULE in 1 BOTTLE (59651-378-05)
ndc11
5965137860
60 CAPSULE in 1 BOTTLE (59651-378-60)

Annotations

UNII (FDA Substance ID)

459384H98V

ZONISAMIDE

RxCUI 39998

Orange Book

A077645

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": "59651-378_b43ac632-68f3-43f6-aa79-41429a54e1ef",
  "productndc": "59651-378",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077645",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Sep 29, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Sep 29, 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": "ANDA077645",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zonisamide",
  "start_marketing_date": "20200817",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N03AX15.

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