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United States · US · US:80425-0408_1bbcb1f8-d717-a171-e063-6394a90a5d98

Eletriptan Hydrobromide

Orange BookUNIISPLATC N02CC06

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN02CC06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8042504081
    1 BLISTER PACK in 1 CARTON (80425-0408-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
M41W832TA3
ELETRIPTAN HYDROBROMIDE
RxCUI 360288
Orange Book
A210708
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "M41W832TA3",
    "rxcui": "360288",
    "inchikey": "UTINOWOSWSPFLJ-FSRHSHDFSA-N",
    "display_name": "ELETRIPTAN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "49686c51-bbd9-45f0-92b1-8ffa81612e35": {
      "match": "brand_token",
      "title": "ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [APNAR PHARMA LP]",
      "spl_version": "2",
      "published_date": "2026-05-21"
    }
  },
  "productid": "80425-0408_1bbcb1f8-d717-a171-e063-6394a90a5d98",
  "productndc": "80425-0408",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210708",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jan 15, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Jan 15, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELETRIPTAN HYDROBROMIDE",
  "proprietary_name": "Eletriptan Hydrobromide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210708",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eletriptan Hydrobromide",
  "start_marketing_date": "20240625",
  "active_numerator_strength": "40"
}

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