Zonisamide

Orange BookUNIISPLATC N03AX15

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN03AX15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6362932931
100 CAPSULE in 1 BOTTLE (63629-3293-1)
ndc11
6362932932
90 CAPSULE in 1 BOTTLE (63629-3293-2)
ndc11
6362932933
30 CAPSULE in 1 BOTTLE (63629-3293-3)
ndc11
6362932934
60 CAPSULE in 1 BOTTLE (63629-3293-4)
ndc11
6362932935
120 CAPSULE in 1 BOTTLE (63629-3293-5)

Annotations

UNII (FDA Substance ID)

459384H98V

ZONISAMIDE

RxCUI 39998

Orange Book

A077634

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": "63629-3293_39303fe6-8d9f-4fa1-91fa-4b012e71d6cc",
  "productndc": "63629-3293",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077634",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 17, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Mar 17, 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": "ANDA077634",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zonisamide",
  "start_marketing_date": "20060317",
  "active_numerator_strength": "100"
}

Related drugs

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