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United States · US · US:69238-1345_efcb5cab-b9c0-4ef9-84fc-5f321c13a0ed
Albuterol
In shortageOrange BookUNIISPLATC R03AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeR03AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116923813451100 TABLET in 1 BOTTLE (69238-1345-1)
- ndc116923813455500 TABLET in 1 BOTTLE (69238-1345-5)
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A208804
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": "69238-1345_efcb5cab-b9c0-4ef9-84fc-5f321c13a0ed",
"productndc": "69238-1345",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208804",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "May 21, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "May 21, 2018"
}
],
"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": "ANDA208804",
"marketing_category": "ANDA",
"nonproprietary_name": "Albuterol",
"start_marketing_date": "20180524",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code R03AC02.
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