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United States · US · US:68788-4056_a2ba9c1d-b21f-4816-bbe6-949a49e38572
Azelastine Hydrochloride
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168788405621 BOTTLE, SPRAY in 1 CARTON (68788-4056-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
0L591QR10I
AZELASTINE HYDROCHLORIDE
RxCUI 235824
Orange Book
A077954
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": "68788-4056_a2ba9c1d-b21f-4816-bbe6-949a49e38572",
"productndc": "68788-4056",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "077954",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.137MG/SPRAY",
"product_no": "001",
"approval_date": "Apr 30, 2009"
}
],
"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": "ug/1",
"application_number": "ANDA077954",
"marketing_category": "ANDA",
"nonproprietary_name": "azelastine hydrochloride",
"start_marketing_date": "20251117",
"active_numerator_strength": "137"
}Related drugs
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