QVAR REDIHALER

Orange BookUNIISPLATC R03BA01

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

Identification

ManufacturerTeva Respiratory, LLC

CountryUS (United States)

ATC codeR03BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5931030480
1 INHALER in 1 CARTON (59310-304-80) / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER
ndc11
5931030481
1 INHALER in 1 CARTON (59310-304-81) / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER

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": "59310-304_9b314255-e511-463f-9cf2-6812cb638cce",
  "productndc": "59310-304",
  "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

Other records sharing ATC code R03BA01.

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