Azelastine Hydrochloride

In shortageOrange BookUNIISPLATC R01AC03

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

Identification

ManufacturerWalgreens

CountryUS (United States)

ATC codeR01AC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0363065302
120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02)
ndc11
0363065303
1 BOTTLE, SPRAY in 1 CARTON (0363-0653-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01)
ndc11
0363065304
1 BOTTLE, SPRAY in 1 CARTON (0363-0653-04) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02)
ndc11
0363065305
2 BOTTLE, SPRAY in 1 CARTON (0363-0653-05) / 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": "0363-0653_52478468-e6b9-4d34-9822-ee138abdecd8",
  "productndc": "0363-0653",
  "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": "20250701",
  "active_numerator_strength": "205.5"
}

Related drugs

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