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United States · US · US:0597-0192_376b43be-46b2-49d7-bc0f-a6408571efea

Striverdi Respimat

Orange BookUNIISPLATC R03AC19

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03AC19
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0597019261
    1 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
65R445W3V9
OLODATEROL HYDROCHLORIDE
RxCUI 1546396
Orange Book
N203108
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "65R445W3V9",
    "rxcui": "1546396",
    "inchikey": "KCEHVJZZIGJAAW-FERBBOLQSA-N",
    "display_name": "OLODATEROL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "5d9a5433-857e-44ea-b3d6-2a400ca0cef5": {
      "match": "brand_token",
      "title": "STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2025-01-14"
    }
  },
  "productid": "0597-0192_376b43be-46b2-49d7-bc0f-a6408571efea",
  "productndc": "0597-0192",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "203108",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.0025MG BASE/INH",
        "product_no": "001",
        "approval_date": "Jul 31, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLODATEROL HYDROCHLORIDE",
  "proprietary_name": "Striverdi Respimat",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA203108",
  "marketing_category": "NDA",
  "nonproprietary_name": "olodaterol respimat inhalation spray",
  "start_marketing_date": "20140801",
  "active_numerator_strength": "2.5"
}

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