QVAR REDIHALER

Orange BookUNIISPLATC R03BA01

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeR03BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009050320
1 INHALER in 1 CARTON (50090-5032-0) / 1 AEROSOL, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)

5B307S63B2

BECLOMETHASONE DIPROPIONATE

RxCUI 1348

Orange Book

N207921

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5B307S63B2",
    "rxcui": "1348",
    "inchikey": "KUVIULQEHSCUHY-XYWKZLDCSA-N",
    "display_name": "BECLOMETHASONE DIPROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "cada897a-264e-450d-ae00-36e7fe747080": {
      "match": "brand_token",
      "title": "QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [TEVA RESPIRATORY, LLC]",
      "spl_version": "16",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50090-5032_778908c5-aa3d-496b-b530-9a5da5eebc6c",
  "productndc": "50090-5032",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "207921",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.04MG/INH",
        "product_no": "001",
        "approval_date": "Aug 3, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.08MG/INH",
        "product_no": "002",
        "approval_date": "Aug 3, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BECLOMETHASONE DIPROPIONATE",
  "proprietary_name": "QVAR REDIHALER",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA207921",
  "marketing_category": "NDA",
  "nonproprietary_name": "Beclomethasone Dipropionate HFA",
  "start_marketing_date": "20180215",
  "active_numerator_strength": "80"
}

Related drugs

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