SEREVENT

Orange BookUNIISPLATC R03AC12

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlaxoSmithKline LLC

CountryUS (United States)

ATC codeR03AC12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0173052100
1 INHALER in 1 CARTON (0173-0521-00) / 60 POWDER, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)

6EW8Q962A5

SALMETEROL XINAFOATE

RxCUI 72616

Orange Book

N020692

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6EW8Q962A5",
    "rxcui": "72616",
    "inchikey": "XTZNCVSCVHTPAI-UHFFFAOYSA-N",
    "display_name": "SALMETEROL XINAFOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL; RESPIRATORY (INHALATION)",
  "spl_meta": {
    "12d9728e-6b5c-4aee-bfb0-745e542ed2e4": {
      "match": "brand_token",
      "title": "SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [GLAXOSMITHKLINE LLC]",
      "spl_version": "31",
      "published_date": "2025-09-15"
    }
  },
  "productid": "0173-0521_5532804f-f5b5-492b-a092-0b1ce60c8de1",
  "productndc": "0173-0521",
  "dosage_form": "POWDER, METERED",
  "orange_book": {
    "appl_no": "020692",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.05MG BASE/INH",
        "product_no": "001",
        "approval_date": "Sep 19, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SALMETEROL XINAFOATE",
  "proprietary_name": "SEREVENT",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA020692",
  "marketing_category": "NDA",
  "nonproprietary_name": "salmeterol xinafoate",
  "start_marketing_date": "19971125",
  "active_numerator_strength": "50"
}

Related drugs

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