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United States · US · US:76204-027_4e7f86ab-55bc-c123-e063-6394a90abd8d
Albuterol Sulfate Inhalation Solution, 0.5%
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 · 1
- ndc11762040270130 POUCH in 1 CARTON (76204-027-01) / 1 VIAL in 1 POUCH (76204-027-11) / .5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A218386
AN
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": "76204-027_4e7f86ab-55bc-c123-e063-6394a90abd8d",
"productndc": "76204-027",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "218386",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Mar 12, 2025"
}
],
"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, 0.5%",
"active_ingred_unit": "mg/.5mL",
"application_number": "ANDA218386",
"marketing_category": "ANDA",
"nonproprietary_name": "Albuterol Sulfate",
"start_marketing_date": "20250324",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code R03AC02.
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