🇺🇸
United States · US · US:69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29
AZELASTINE HYDROCHLORIDE
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllegiant Health
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1169168478022 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
- ndc1169168478631 BOTTLE, SPRAY in 1 CARTON (69168-478-63) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
0L591QR10I
AZELASTINE HYDROCHLORIDE
RxCUI 235824
Orange Book
A216421
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": "69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29",
"productndc": "69168-478",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "216421",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.2055MG/SPRAY",
"product_no": "001",
"approval_date": "May 29, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.2055MG/SPRAY",
"product_no": "002",
"approval_date": "May 29, 2024"
}
],
"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": "ANDA216421",
"marketing_category": "ANDA",
"nonproprietary_name": "AZELASTINE HYDROCHLORIDE",
"start_marketing_date": "20250502",
"active_numerator_strength": "205.5"
}Related drugs
Other records sharing ATC code R01AC03.
- PLAcatar AllergyUS Pharmacia Sp. z o.o.
- GBAller-Eze 0.05% eye dropsNovartis Consumer Health UK Ltd
- GBAller-Eze 140micrograms/dose nasal sprayNovartis Consumer Health UK Ltd
- PLAllergodilCooper Consumer Health B.V.
- DKAllergodilCooper Consumer Health B.V.
- CZALLERGODILVIATRIS HEALTHCARE LIMITED, Dublin
- CZALLERGODILCooper Consumer Health B.V., Diemen
- CZALLERGODILVIATRIS HEALTHCARE LIMITED, Dublin
Access this data programmatically
Query AZELASTINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.