Ipratropium Bromide and Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeR03AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7120572615
1 POUCH in 1 BAG (71205-726-15) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

021SEF3731

ALBUTEROL SULFATE

RxCUI 142153

Orange Book

A207875

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Albuterol Sulfate Solution

Raw payload (JSON)

{
  "unii": {
    "unii": "021SEF3731",
    "rxcui": "142153",
    "inchikey": "BNPSSFBOAGDEEL-UHFFFAOYSA-N",
    "display_name": "ALBUTEROL SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "52c63e41-dbbc-d9d7-e063-6294a90a30c9": {
      "match": "brand_token",
      "title": "IPRATROPIUM BROMIDE SOLUTION [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71205-726_0b0587df-b4bd-4fae-9d79-c71362c0314b",
  "productndc": "71205-726",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "207875",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.083% BASE;0.017%",
        "product_no": "001",
        "approval_date": "Aug 7, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE",
  "shortage_reason": "Albuterol Sulfate Solution",
  "shortage_status": "current",
  "proprietary_name": "Ipratropium Bromide and Albuterol Sulfate",
  "active_ingred_unit": "mg/3mL; mg/3mL",
  "application_number": "ANDA207875",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ipratropium Bromide and Albuterol Sulfate",
  "start_marketing_date": "20211115",
  "active_numerator_strength": "2.5; .5"
}

Related drugs

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