Eletriptan Hydrobromide

Orange BookUNIISPLATC N02CC06

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN02CC06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0378428808
2 BLISTER PACK in 1 CARTON (0378-4288-08) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)
ndc11
0378428885
1 BLISTER PACK in 1 CARTON (0378-4288-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)

Annotations

UNII (FDA Substance ID)

M41W832TA3

ELETRIPTAN HYDROBROMIDE

RxCUI 360288

Orange Book

A205152

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": "0378-4288_cba8e2c4-eb4b-49c7-83be-d5cfb58b23d9",
  "productndc": "0378-4288",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205152",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Aug 11, 2017"
      }
    ],
    "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": "ANDA205152",
  "marketing_category": "ANDA",
  "nonproprietary_name": "eletriptan hydrobromide",
  "start_marketing_date": "20170815",
  "active_numerator_strength": "40"
}

Related drugs

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