Back to search
🇺🇸

United States · US · US:59310-580_4d670f5c-7719-4e68-8a96-dcd26421d29c

ProAir RespiClick

In shortageOrange BookUNIISPLATC R03AC02

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

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
    5931058020
    1 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED 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": "59310-580_4d670f5c-7719-4e68-8a96-dcd26421d29c",
  "productndc": "59310-580",
  "dosage_form": "POWDER, METERED",
  "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 RespiClick",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205636",
  "marketing_category": "NDA",
  "nonproprietary_name": "Albuterol Sulfate",
  "start_marketing_date": "20150423",
  "active_numerator_strength": "90"
}

Related drugs

Other records sharing ATC code R03AC02.

Access this data programmatically

Query ProAir RespiClick 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.