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United States · US · US:68788-8492_84a25c79-3c24-4979-b295-2495b90eb295
Albuterol Sulfate
In shortageOrange BookUNIISPLATC R03AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR03AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168788849225 POUCH in 1 CARTON (68788-8492-2) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A207857
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": "68788-8492_84a25c79-3c24-4979-b295-2495b90eb295",
"productndc": "68788-8492",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "207857",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "EQ 0.083% BASE",
"product_no": "001",
"approval_date": "Jul 21, 2017"
}
],
"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/mL",
"application_number": "ANDA207857",
"marketing_category": "ANDA",
"nonproprietary_name": "albuterol sulfate",
"start_marketing_date": "20230724",
"active_numerator_strength": ".83"
}Related drugs
Other records sharing ATC code R03AC02.
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