ProAir Digihaler

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerTeva Respiratory, LLC

CountryUS (United States)

ATC codeR03AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5931011720
1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALER

Annotations

UNII (FDA Substance ID)

021SEF3731

ALBUTEROL SULFATE

RxCUI 142153

Orange Book

N205636

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": {
    "667ce3ec-5217-4b10-b712-f3e54fbbf087": {
      "match": "brand_token",
      "title": "PROAIR DIGIHALER (ALBUTEROL SULFATE) POWDER, METERED PROAIR DIGIHALER (ALBUTEROL SULFATE) INHALANT [TEVA RESPIRATORY, LLC]",
      "spl_version": "26",
      "published_date": "2024-05-15"
    }
  },
  "productid": "59310-117_6d6a3e12-ee60-4cec-9f1b-df00c47b769f",
  "productndc": "59310-117",
  "dosage_form": "INHALANT",
  "orange_book": {
    "appl_no": "205636",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.09MG BASE/INH",
        "product_no": "001",
        "approval_date": "Mar 31, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.09MG BASE/INH",
        "product_no": "002",
        "approval_date": "Dec 21, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBUTEROL SULFATE",
  "shortage_reason": "Albuterol Sulfate Solution",
  "shortage_status": "current",
  "proprietary_name": "ProAir Digihaler",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205636",
  "marketing_category": "NDA",
  "nonproprietary_name": "albuterol sulfate",
  "start_marketing_date": "20191004",
  "active_numerator_strength": "90"
}

Related drugs

Other records sharing ATC code R03AC02.

Access this data programmatically

Query ProAir Digihaler and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs