DYMISTA

In shortageOrange BookUNIISPLATC R01AC

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeR01AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0037024523
1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)

0L591QR10I

AZELASTINE HYDROCHLORIDE

RxCUI 235824

Orange Book

N202236

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": {
    "4c557ec4-c4cf-11df-851a-0800200c9a66": {
      "match": "brand_token",
      "title": "DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [VIATRIS SPECIALTY LLC]",
      "spl_version": "21",
      "published_date": "2025-08-25"
    }
  },
  "productid": "0037-0245_ed1f7ce9-ccfa-4e73-940f-14ea8166d524",
  "productndc": "0037-0245",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "202236",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.137MG/SPRAY;0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "May 1, 2012"
      }
    ],
    "appl_type": "N"
  },
  "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": "DYMISTA",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA202236",
  "marketing_category": "NDA",
  "nonproprietary_name": "Azelastine Hydrochloride and Fluticasone Propionate",
  "start_marketing_date": "20161001",
  "active_numerator_strength": "137; 50"
}

Related drugs

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