fluticasone propionate and salmeterol

In shortageOrange BookUNIISPLATC D07AC

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeD07AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051839680
1 POUCH in 1 CARTON (70518-3968-0) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER

Annotations

UNII (FDA Substance ID)

O2GMZ0LF5W

FLUTICASONE PROPIONATE

RxCUI 50121

Orange Book

A203433

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Fluticasone Propionate; Salmeterol Xinafoate Powder

Raw payload (JSON)

{
  "unii": {
    "unii": "O2GMZ0LF5W",
    "rxcui": "50121",
    "inchikey": "WMWTYOKRWGGJOA-CENSZEJFSA-N",
    "display_name": "FLUTICASONE PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "da4e897e-9be1-499a-8889-15398b30ef3b": {
      "match": "brand_token",
      "title": "FLUTICASONE PROPIONATE DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-05-20"
    }
  },
  "productid": "70518-3968_3c2a6b48-c02c-2148-e063-6394a90a4bfa",
  "productndc": "70518-3968",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "203433",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG/INH;EQ 0.05MG BASE/INH",
        "product_no": "001",
        "approval_date": "Dec 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG/INH;EQ 0.05MG BASE/INH",
        "product_no": "002",
        "approval_date": "Dec 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG/INH;EQ 0.05MG BASE/INH",
        "product_no": "003",
        "approval_date": "Dec 19, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "fluticasone propionate and salmeterol",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "ANDA203433",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluticasone propionate and salmeterol",
  "start_marketing_date": "20231226",
  "active_numerator_strength": "250; 50"
}

Related drugs

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