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United States · US · US:65162-676_0ead3061-d60d-4911-91cc-489d3b5fe573
Azelastine Hydrochloride
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165162676841 BOTTLE, SPRAY in 1 CARTON (65162-676-84) / 30 mL in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
0L591QR10I
AZELASTINE HYDROCHLORIDE
RxCUI 235824
Orange Book
A204660
AB
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": "65162-676_0ead3061-d60d-4911-91cc-489d3b5fe573",
"productndc": "65162-676",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "204660",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.137MG/SPRAY",
"product_no": "001",
"approval_date": "Aug 28, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZELASTINE HYDROCHLORIDE",
"shortage_reason": "Azelastine Hydrochloride; Fluticasone Propionate Nasal Spray",
"shortage_status": "current",
"proprietary_name": "Azelastine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA204660",
"marketing_category": "ANDA",
"nonproprietary_name": "Azelastine",
"start_marketing_date": "20170905",
"active_numerator_strength": "1"
}Related drugs
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