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United States · US · US:50090-2330_d2dfdb55-40a8-441e-8454-9f3b1eb3e89d

Azelastine Hydrochloride

In shortageOrange BookUNIISPLATC R01AC03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR01AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009023300
    1 BOTTLE, SPRAY in 1 CARTON (50090-2330-0) / 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": "50090-2330_d2dfdb55-40a8-441e-8454-9f3b1eb3e89d",
  "productndc": "50090-2330",
  "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": "20100301",
  "active_numerator_strength": "137"
}

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