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United States · US · US:27437-056_905559df-c984-469d-b6b1-a38fdc320471
XOPENEX HFA
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1127437056011 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER
Annotations
UNII (FDA Substance ID)
ADS4I3E22M
LEVALBUTEROL TARTRATE
RxCUI 487066
Orange Book
N021730
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ADS4I3E22M",
"rxcui": "487066",
"inchikey": "VNVNZKCCDVFGAP-FPDJQMMJSA-N",
"display_name": "LEVALBUTEROL TARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"70a35706-d7a8-4a48-98c6-1cab1c42fe8d": {
"match": "brand_token",
"title": "XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [LUPIN PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2025-07-30"
}
},
"productid": "27437-056_905559df-c984-469d-b6b1-a38fdc320471",
"productndc": "27437-056",
"dosage_form": "AEROSOL, METERED",
"orange_book": {
"appl_no": "021730",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.045MG BASE/INH",
"product_no": "001",
"approval_date": "Mar 11, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVALBUTEROL TARTRATE",
"proprietary_name": "XOPENEX HFA",
"active_ingred_unit": "ug/1",
"application_number": "NDA021730",
"marketing_category": "NDA",
"nonproprietary_name": "levalbuterol tartrate",
"start_marketing_date": "20231110",
"active_numerator_strength": "45"
}Access this data programmatically
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