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United States · US · US:51316-840_996da2f2-ced4-407a-acd6-4c72036c51ef
Azelastine Hydrochloride
In shortageOrange BookUNIISPLATC R01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS PHARMACY, INC
CountryUS (United States)
ATC codeR01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1151316840011 BOTTLE, SPRAY in 1 CARTON (51316-840-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-02)
- ndc115131684002120 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-02)
- ndc1151316840031 BOTTLE, SPRAY in 1 CARTON (51316-840-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
- ndc11513168400460 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-04)
- ndc1151316840052 BOTTLE, SPRAY in 1 CARTON (51316-840-05) / 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": "51316-840_996da2f2-ced4-407a-acd6-4c72036c51ef",
"productndc": "51316-840",
"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": "20250801",
"active_numerator_strength": "205.5"
}Related drugs
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