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United States · US · US:58602-020_408b5706-3b4c-4eaf-8d03-b4e26485c06b
AZELASTINE HYDROCHLORIDE
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1158602020071 BOTTLE, SPRAY in 1 CARTON (58602-020-07) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
- ndc1158602020511 BOTTLE, SPRAY in 1 CARTON (58602-020-51) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
- ndc1158602020521 BOTTLE, SPRAY in 1 CARTON (58602-020-52) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
0L591QR10I
AZELASTINE HYDROCHLORIDE
RxCUI 235824
Orange Book
A216561
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": {
"22d516d0-da22-4e3b-a4a5-135b009bc968": {
"match": "brand_token",
"title": "AZELASTINE HYDROCHLORIDE SPRAY, METERED [CVS PHARMACY, INC]",
"spl_version": "5",
"published_date": "2026-05-25"
}
},
"productid": "58602-020_408b5706-3b4c-4eaf-8d03-b4e26485c06b",
"productndc": "58602-020",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "216561",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.2055MG/SPRAY",
"product_no": "001",
"approval_date": "Jan 27, 2025"
}
],
"appl_type": "A"
},
"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": "AZELASTINE HYDROCHLORIDE",
"active_ingred_unit": "ug/1",
"application_number": "ANDA216561",
"marketing_category": "ANDA",
"nonproprietary_name": "AZELASTINE HYDROCHLORIDE",
"start_marketing_date": "20250127",
"active_numerator_strength": "205.5"
}Related drugs
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