Azelastine Hydrochloride and Fluticasone Propionate

In shortageOrange BookUNIISPLATC R01AC

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeR01AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480215757
1 BOTTLE, SPRAY in 1 CARTON (0480-2157-57) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)

0L591QR10I

AZELASTINE HYDROCHLORIDE

RxCUI 235824

Orange Book

A208436

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": "0480-2157_edea3e4b-7afc-4566-864d-acdf480a92af",
  "productndc": "0480-2157",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "208436",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.137MG/SPRAY;0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "Apr 8, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE",
  "shortage_reason": "Azelastine Hydrochloride; Fluticasone Propionate Nasal Spray",
  "shortage_status": "current",
  "proprietary_name": "Azelastine Hydrochloride and Fluticasone Propionate",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "ANDA208436",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azelastine Hydrochloride and Fluticasone Propionate",
  "start_marketing_date": "20250908",
  "active_numerator_strength": "137; 50"
}

Related drugs

Other records sharing ATC code R01AC.

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