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United States · US · US:47335-938_b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b
Azelastine Hydrochloride
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1147335938901 BOTTLE, PLASTIC in 1 BOX (47335-938-90) / 6 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
0L591QR10I
AZELASTINE HYDROCHLORIDE
RxCUI 235824
Orange Book
A078738
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": "47335-938_b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b",
"productndc": "47335-938",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "078738",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.05%",
"product_no": "001",
"approval_date": "Jun 21, 2010"
}
],
"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": "ANDA078738",
"marketing_category": "ANDA",
"nonproprietary_name": "Azelastine Hydrochloride",
"start_marketing_date": "20100531",
"active_numerator_strength": ".5"
}Related drugs
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