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United States · US · US:0310-9080_8738de51-e5d3-4ac5-910d-a155169ab78e

AIRSUPRA

In shortageOrange BookUNIISPLATC R03AC

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

Identification

ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeR03AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0310908012
    1 INHALER in 1 CARTON (0310-9080-12) / 120 AEROSOL, METERED in 1 INHALER
  • ndc11
    0310908028
    1 INHALER in 1 CARTON (0310-9080-28) / 28 AEROSOL, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
N214070
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Albuterol Sulfate Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "021SEF3731",
    "rxcui": "142153",
    "inchikey": "BNPSSFBOAGDEEL-UHFFFAOYSA-N",
    "display_name": "ALBUTEROL SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "e60aa9f9-5139-44df-b886-ebddc3c7eb13": {
      "match": "brand_token",
      "title": "AIRSUPRA (ALBUTEROL SULFATE AND BUDESONIDE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "10",
      "published_date": "2025-09-22"
    }
  },
  "productid": "0310-9080_8738de51-e5d3-4ac5-910d-a155169ab78e",
  "productndc": "0310-9080",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "214070",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.09MG BASE/INH;0.08MG/INH",
        "product_no": "001",
        "approval_date": "Jan 10, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBUTEROL SULFATE; BUDESONIDE",
  "shortage_reason": "Albuterol Sulfate Solution",
  "shortage_status": "current",
  "proprietary_name": "AIRSUPRA",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA214070",
  "marketing_category": "NDA",
  "nonproprietary_name": "Albuterol sulfate and budesonide",
  "start_marketing_date": "20231002",
  "active_numerator_strength": "90; 80"
}

Related drugs

Other records sharing ATC code R03AC.

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