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United States · US · US:58151-367_ca50a848-b287-47b6-980b-5729d4582893

Relpax

Orange BookUNIISPLATC N02CC06

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

Identification

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

Packs · 1

  • ndc11
    5815136756
    6 BLISTER PACK in 1 CARTON (58151-367-56) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
M41W832TA3
ELETRIPTAN HYDROBROMIDE
RxCUI 360288
Orange Book
N021016
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": {
    "2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e": {
      "match": "brand_token",
      "title": "RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET [VIATRIS SPECIALTY LLC]",
      "spl_version": "4",
      "published_date": "2025-05-12"
    }
  },
  "productid": "58151-367_ca50a848-b287-47b6-980b-5729d4582893",
  "productndc": "58151-367",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021016",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Dec 26, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Dec 26, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELETRIPTAN HYDROBROMIDE",
  "proprietary_name": "Relpax",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021016",
  "marketing_category": "NDA",
  "nonproprietary_name": "eletriptan hydrobromide",
  "start_marketing_date": "20250508",
  "active_numerator_strength": "20"
}

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