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United States · US · US:70515-712_3a8b4338-890b-bc2f-e063-6394a90ab578
Alvesco
Orange BookUNIISPLATC R03BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCovis Pharma US, Inc
CountryUS (United States)
ATC codeR03BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1170515712011 INHALER in 1 CARTON (70515-712-01) / 60 AEROSOL, METERED in 1 INHALER
- ndc1170515712021 INHALER in 1 CARTON (70515-712-02) / 60 AEROSOL, METERED in 1 INHALER
- ndc1170515712031 INHALER in 1 CARTON (70515-712-03) / 30 AEROSOL, METERED in 1 INHALER
- ndc1170515712041 INHALER in 1 CARTON (70515-712-04) / 30 AEROSOL, METERED in 1 INHALER
- ndc1170515712051 INHALER in 1 CARTON (70515-712-05) / 60 AEROSOL, METERED in 1 INHALER
Annotations
UNII (FDA Substance ID)
S59502J185
CICLESONIDE
RxCUI 274964
Orange Book
N021658
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "S59502J185",
"rxcui": "274964",
"inchikey": "LUKZNWIVRBCLON-GXOBDPJESA-N",
"display_name": "CICLESONIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"9f6112fb-78ef-43cf-8ae3-36370eb45468": {
"match": "brand_token",
"title": "ALVESCO (CICLESONIDE) AEROSOL, METERED [COVIS PHARMA US, INC]",
"spl_version": "8",
"published_date": "2025-07-24"
}
},
"productid": "70515-712_3a8b4338-890b-bc2f-e063-6394a90ab578",
"productndc": "70515-712",
"dosage_form": "AEROSOL, METERED",
"orange_book": {
"appl_no": "021658",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.08MG/INH",
"product_no": "002",
"approval_date": "Jan 10, 2008"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.16MG/INH",
"product_no": "003",
"approval_date": "Jan 10, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CICLESONIDE",
"proprietary_name": "Alvesco",
"active_ingred_unit": "ug/1",
"application_number": "NDA021658",
"marketing_category": "NDA",
"nonproprietary_name": "ciclesonide",
"start_marketing_date": "20180326",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code R03BA08.
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