zolmiptriptan

Orange BookUNIISPLATC N02CC03

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeN02CC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846250033
1 BLISTER PACK in 1 CARTON (68462-500-33) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-500-40)

Annotations

UNII (FDA Substance ID)

2FS66TH3YW

ZOLMITRIPTAN

RxCUI 135775

Orange Book

A202560

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2FS66TH3YW",
    "rxcui": "135775",
    "inchikey": "ULSDMUVEXKOYBU-ZDUSSCGKSA-N",
    "display_name": "ZOLMITRIPTAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a734b368-6008-441c-ab44-5634e46be9a4": {
      "match": "brand_token",
      "title": "ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "14",
      "published_date": "2026-01-30"
    }
  },
  "productid": "68462-500_977ca814-2c55-4de0-a75e-9e42f2e86f77",
  "productndc": "68462-500",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "202560",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "May 14, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "May 14, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLMITRIPTAN",
  "proprietary_name": "zolmiptriptan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202560",
  "marketing_category": "ANDA",
  "nonproprietary_name": "zolmitriptan",
  "start_marketing_date": "20130514",
  "active_numerator_strength": "5"
}

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