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United States · US · US:53489-176_4d289f6d-634d-2125-e063-6394a90aa25d
albuterol sulfate
In shortageOrange BookUNIISPLATC R03AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeR03AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115348917601100 TABLET in 1 BOTTLE (53489-176-01)
- ndc11534891760250 TABLET in 1 BOTTLE (53489-176-02)
- ndc115348917603250 TABLET in 1 BOTTLE (53489-176-03)
- ndc115348917605500 TABLET in 1 BOTTLE (53489-176-05)
- ndc1153489176101000 TABLET in 1 BOTTLE (53489-176-10)
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A072637
ABAB
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": "53489-176_4d289f6d-634d-2125-e063-6394a90aa25d",
"productndc": "53489-176",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "072637",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "001",
"approval_date": "Dec 5, 1989"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Dec 5, 1989"
}
],
"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 sulfate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA072637",
"marketing_category": "ANDA",
"nonproprietary_name": "albuterol sulfate",
"start_marketing_date": "19891205",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code R03AC02.
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