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United States · US · US:59651-334_f89dffb1-5c4b-48aa-90b4-74043fc9b690
Albuterol
In shortageOrange BookUNIISPLATC R03AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeR03AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115965133401100 TABLET in 1 BOTTLE (59651-334-01)
- ndc115965133405500 TABLET in 1 BOTTLE (59651-334-05)
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A213657
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": "ORAL",
"spl_meta": {
"b0a5da99-6553-4088-ae27-7fa194438340": {
"match": "brand_token",
"title": "ALBUTEROL SULFATE INHALANT [AMERICAN HEALTH PACKAGING]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "59651-334_f89dffb1-5c4b-48aa-90b4-74043fc9b690",
"productndc": "59651-334",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213657",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "May 14, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "May 14, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALBUTEROL SULFATE",
"shortage_reason": "Albuterol Sulfate Solution",
"shortage_status": "current",
"proprietary_name": "Albuterol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213657",
"marketing_category": "ANDA",
"nonproprietary_name": "Albuterol",
"start_marketing_date": "20200514",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code R03AC02.
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