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United States · US · US:76204-011_4ffd498d-4575-dd61-e063-6394a90a95d6
Albuterol Sulfate Inhalation Solution
In shortageOrange BookUNIISPLATC R03AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRitedose Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR03AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11762040110130 POUCH in 1 CARTON (76204-011-01) / 1 VIAL in 1 POUCH (76204-011-11) / 3 mL in 1 VIAL
- ndc11762040115525 POUCH in 1 CARTON (76204-011-55) / 5 VIAL in 1 POUCH (76204-011-05) / 3 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A214531
ANAN
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": {
"b0a5da99-6553-4088-ae27-7fa194438340": {
"match": "brand_token",
"title": "ALBUTEROL SULFATE INHALANT [AMERICAN HEALTH PACKAGING]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "76204-011_4ffd498d-4575-dd61-e063-6394a90a95d6",
"productndc": "76204-011",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "214531",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AN",
"strength": "EQ 0.021% BASE",
"product_no": "001",
"approval_date": "Dec 28, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "EQ 0.042% BASE",
"product_no": "002",
"approval_date": "Dec 28, 2021"
}
],
"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 Inhalation Solution",
"active_ingred_unit": "mg/3mL",
"application_number": "ANDA214531",
"marketing_category": "ANDA",
"nonproprietary_name": "Albuterol Sulfate",
"start_marketing_date": "20220104",
"active_numerator_strength": "1.25"
}Related drugs
Other records sharing ATC code R03AC02.
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