Zonisamide

Orange BookUNIISPLATC N03AX15

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN03AX15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7051846000
100 POUCH in 1 BOX (70518-4600-0) / 1 CAPSULE in 1 POUCH (70518-4600-1)
ndc11
7051846002
50 POUCH in 1 BOX (70518-4600-2) / 1 CAPSULE in 1 POUCH (70518-4600-1)

Annotations

UNII (FDA Substance ID)

459384H98V

ZONISAMIDE

RxCUI 39998

Orange Book

A077651

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": "70518-4600_52cfd84c-67da-2c6b-e063-6394a90a0c93",
  "productndc": "70518-4600",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077651",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Jan 30, 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": "ANDA077651",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zonisamide",
  "start_marketing_date": "20260331",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N03AX15.

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