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United States · US · US:68999-189_462ca25f-d461-c069-e063-6394a90a528a
ALBUTEROL SULFATE
In shortageOrange BookUNIISPLATC R03AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell Governmental & Specialty RX, LLC.
CountryUS (United States)
ATC codeR03AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168999189232 TRAY in 1 BOX (68999-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-189-20)
- ndc1168999189242 TRAY in 1 BOX (68999-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-189-05)
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A077788
AA
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": "68999-189_462ca25f-d461-c069-e063-6394a90a528a",
"productndc": "68999-189",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "077788",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 2MG BASE/5ML",
"product_no": "001",
"approval_date": "Jun 26, 2007"
}
],
"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/5mL",
"application_number": "ANDA077788",
"marketing_category": "ANDA",
"nonproprietary_name": "Albuterol Sulfate",
"start_marketing_date": "20070626",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code R03AC02.
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