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United States · US · US:0093-8311_fe826d95-af0c-490d-8a5d-02218c836ff8

Eletriptan Hydrobromide

Orange BookUNIISPLATC N02CC06

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

Identification

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

Packs · 1

  • ndc11
    0093831118
    6 BLISTER PACK in 1 CARTON (0093-8311-18) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-8311-19)

Annotations

UNII (FDA Substance ID)
M41W832TA3
ELETRIPTAN HYDROBROMIDE
RxCUI 360288
Orange Book
A202040
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": "0093-8311_fe826d95-af0c-490d-8a5d-02218c836ff8",
  "productndc": "0093-8311",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202040",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jun 27, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Jun 27, 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": "ANDA202040",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eletriptan Hydrobromide",
  "start_marketing_date": "20170721",
  "active_numerator_strength": "40"
}

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