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United States · US · US:0280-0066_45263d0f-63fd-7187-e063-6394a90a06c0
Children Astepro Allergy
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare LLC.
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11028000660160 CARTON in 1 BOTTLE (0280-0066-01) / 1 SPRAY, METERED in 1 CARTON
- ndc110280006602120 CARTON in 1 BOTTLE (0280-0066-02) / 1 SPRAY, METERED in 1 CARTON
- ndc11028000660322 CARTON in 1 BOTTLE (0280-0066-03) / 1 SPRAY, METERED in 1 CARTON
Annotations
UNII (FDA Substance ID)
0L591QR10I
AZELASTINE HYDROCHLORIDE
RxCUI 235824
Orange Book
N213872
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azelastine Hydrochloride; Fluticasone Propionate Nasal Spray
Raw payload (JSON)
{
"unii": {
"unii": "0L591QR10I",
"rxcui": "235824",
"inchikey": "YEJAJYAHJQIWNU-UHFFFAOYSA-N",
"display_name": "AZELASTINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"a26c3515-4a24-4988-b9bb-813420b15630": {
"match": "brand_token",
"title": "CHILDREN ALLERGY (FEXOFENADINE HCL) SUSPENSION [H E B]",
"spl_version": "3",
"published_date": "2026-05-13"
}
},
"productid": "0280-0066_45263d0f-63fd-7187-e063-6394a90a06c0",
"productndc": "0280-0066",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "213872",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.2055MG/SPRAY",
"product_no": "001",
"approval_date": "Jun 17, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.2055MG/SPRAY",
"product_no": "002",
"approval_date": "Jun 17, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "AZELASTINE HYDROCHLORIDE",
"shortage_reason": "Azelastine Hydrochloride; Fluticasone Propionate Nasal Spray",
"shortage_status": "current",
"proprietary_name": "Children Astepro Allergy",
"active_ingred_unit": "ug/1",
"application_number": "NDA213872",
"marketing_category": "NDA",
"nonproprietary_name": "Azelastine HCl",
"start_marketing_date": "20220627",
"active_numerator_strength": "205.5"
}Related drugs
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- PLAllergodilCooper Consumer Health B.V.
- DKAllergodilCooper Consumer Health B.V.
- CZALLERGODILVIATRIS HEALTHCARE LIMITED, Dublin
- CZALLERGODILCooper Consumer Health B.V., Diemen
- CZALLERGODILVIATRIS HEALTHCARE LIMITED, Dublin
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