ZOMIG

Orange BookUNIISPLATC N02CC03

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeN02CC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6489608312
6 BOTTLE, SPRAY in 1 CARTON (64896-083-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)

2FS66TH3YW

ZOLMITRIPTAN

RxCUI 135775

Orange Book

N021450

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": "NASAL",
  "spl_meta": {
    "2438c223-605b-4885-afc3-a6794f190f89": {
      "match": "brand_token",
      "title": "ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "6",
      "published_date": "2026-03-20"
    }
  },
  "productid": "64896-083_00c29925-0e82-4be0-b335-efb0e4ffa0fc",
  "productndc": "64896-083",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "021450",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG/SPRAY",
        "product_no": "003",
        "approval_date": "Sep 16, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG/SPRAY",
        "product_no": "004",
        "approval_date": "Sep 30, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOLMITRIPTAN",
  "proprietary_name": "ZOMIG",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021450",
  "marketing_category": "NDA",
  "nonproprietary_name": "Zolmitriptan",
  "start_marketing_date": "20240715",
  "active_numerator_strength": "2.5"
}

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