Zolmitriptan

Orange BookUNIISPLATC N02CC03

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN02CC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6838271701
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-01)
ndc11
6838271706
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-06)
ndc11
6838271710
1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-10)
ndc11
6838271716
90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-16)
ndc11
6838271777
10 BLISTER PACK in 1 CARTON (68382-717-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-30)
ndc11
6838271782
1 BLISTER PACK in 1 CARTON (68382-717-82) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-87)

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": "68382-717_c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310",
  "productndc": "68382-717",
  "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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