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United States · US · US:0173-0681_244881b7-a19f-4409-abf7-2df6ad39c28e

RELENZA

Orange BookUNIISPLATC J05AH01

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

Identification

ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeJ05AH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0173068101
    5 PACKAGE in 1 CARTON (0173-0681-01) / 4 POWDER in 1 PACKAGE
  • ndc11
    0173068122
    5 PACKAGE in 1 CARTON (0173-0681-22) / 4 POWDER in 1 PACKAGE

Annotations

UNII (FDA Substance ID)
L6O3XI777I
ZANAMIVIR
RxCUI 69722
Orange Book
N021036
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "L6O3XI777I",
    "rxcui": "69722",
    "inchikey": "ARAIBEBZBOPLMB-UFGQHTETSA-N",
    "display_name": "ZANAMIVIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "d7c3bcc3-0c0d-4068-fd80-88cf54a376ef": {
      "match": "brand_token",
      "title": "RELENZA (ZANAMIVIR) POWDER [GLAXOSMITHKLINE LLC]",
      "spl_version": "33",
      "published_date": "2025-07-14"
    }
  },
  "productid": "0173-0681_244881b7-a19f-4409-abf7-2df6ad39c28e",
  "productndc": "0173-0681",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "021036",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 26, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZANAMIVIR",
  "proprietary_name": "RELENZA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021036",
  "marketing_category": "NDA",
  "nonproprietary_name": "zanamivir",
  "start_marketing_date": "19990922",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code J05AH01.

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