zonisamide

Orange BookUNIISPLATC N03AX15

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

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeN03AX15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6909786107
100 CAPSULE in 1 BOTTLE (69097-861-07)
ndc11
6909786112
500 CAPSULE in 1 BOTTLE (69097-861-12)

Annotations

UNII (FDA Substance ID)

459384H98V

ZONISAMIDE

RxCUI 39998

Orange Book

A077869

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": "69097-861_37025923-f696-46ab-95fb-b38c30e6004b",
  "productndc": "69097-861",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077869",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 31, 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": "ANDA077869",
  "marketing_category": "ANDA",
  "nonproprietary_name": "zonisamide",
  "start_marketing_date": "20160713",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AX15.

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