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 · 4

ndc11
7133527961
60 CAPSULE in 1 BOTTLE (71335-2796-1)
ndc11
7133527962
90 CAPSULE in 1 BOTTLE (71335-2796-2)
ndc11
7133527963
30 CAPSULE in 1 BOTTLE (71335-2796-3)
ndc11
7133527964
70 CAPSULE in 1 BOTTLE (71335-2796-4)

Annotations

UNII (FDA Substance ID)

459384H98V

ZONISAMIDE

RxCUI 39998

Orange Book

A077625

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": "71335-2796_94aeaba7-6c30-45d2-9dce-0b4fd4f3feb1",
  "productndc": "71335-2796",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077625",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Oct 16, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Oct 16, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Oct 16, 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": "ANDA077625",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zonisamide",
  "start_marketing_date": "20220704",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N03AX15.

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