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United States · US · US:68083-287_a29e9f18-dc8f-491a-b502-e26c0d8bfe08
Azelastine Hydrochloride
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083287011 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 6 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
0L591QR10I
AZELASTINE HYDROCHLORIDE
RxCUI 235824
Orange Book
A210092
AT
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": "INTRAOCULAR",
"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": "68083-287_a29e9f18-dc8f-491a-b502-e26c0d8bfe08",
"productndc": "68083-287",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "210092",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Feb 25, 2020"
}
],
"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": "ANDA210092",
"marketing_category": "ANDA",
"nonproprietary_name": "Azelastine Hydrochloride",
"start_marketing_date": "20200225",
"active_numerator_strength": ".5"
}Related drugs
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