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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
- ndc1159310580201 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.
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