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United States · US · US:68382-922_669aad4d-c160-4be8-bca9-bdbaf0f3c8a3

Eletriptan hydrobromide

Orange BookUNIISPLATC N02CC06

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN02CC06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6838292206
    30 TABLET, FILM COATED in 1 BOTTLE (68382-922-06)
  • ndc11
    6838292210
    1000 TABLET, FILM COATED in 1 BOTTLE (68382-922-10)
  • ndc11
    6838292277
    10 BLISTER PACK in 1 CARTON (68382-922-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-922-30)
  • ndc11
    6838292286
    1 BLISTER PACK in 1 CARTON (68382-922-86) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
M41W832TA3
ELETRIPTAN HYDROBROMIDE
RxCUI 360288
Orange Book
A206409
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": "68382-922_669aad4d-c160-4be8-bca9-bdbaf0f3c8a3",
  "productndc": "68382-922",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206409",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jun 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Jun 16, 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": "ANDA206409",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eletriptan hydrobromide",
  "start_marketing_date": "20170712",
  "active_numerator_strength": "20"
}

Related drugs

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