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United States · US · US:72189-517_2c4e7a35-ff54-4971-e063-6294a90ae9df

Eletriptan HBR

Orange BookUNIISPLATC N02CC06

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

Identification

ManufacturerDirect_Rx
CountryUS (United States)
ATC codeN02CC06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7218951706
    6 TABLET, FILM COATED in 1 CARTON (72189-517-06)

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": "72189-517_2c4e7a35-ff54-4971-e063-6294a90ae9df",
  "productndc": "72189-517",
  "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 HBR",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210708",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eletriptan HBR",
  "start_marketing_date": "20231011",
  "active_numerator_strength": "40"
}

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