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United States · US · US:65841-768_31419037-52ae-41bb-a03e-8965205ab347

Zolmitriptan

Orange BookUNIISPLATC N02CC03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN02CC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6584176801
    100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-01)
  • ndc11
    6584176806
    30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-06)
  • ndc11
    6584176810
    1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-10)
  • ndc11
    6584176816
    90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-16)
  • ndc11
    6584176877
    10 BLISTER PACK in 1 CARTON (65841-768-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-30)
  • ndc11
    6584176882
    1 BLISTER PACK in 1 CARTON (65841-768-82) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-87)

Annotations

UNII (FDA Substance ID)
2FS66TH3YW
ZOLMITRIPTAN
RxCUI 135775
Orange Book
A202890
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": {
    "e6628b7a-0b63-4e6f-a5e7-2fa195265235": {
      "match": "brand_token",
      "title": "ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]",
      "spl_version": "7",
      "published_date": "2026-04-17"
    }
  },
  "productid": "65841-768_31419037-52ae-41bb-a03e-8965205ab347",
  "productndc": "65841-768",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "202890",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "May 15, 2013"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "May 15, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLMITRIPTAN",
  "proprietary_name": "Zolmitriptan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202890",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zolmitriptan",
  "start_marketing_date": "20130516",
  "active_numerator_strength": "5"
}

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