IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

In shortageOrange BookUNIISPLATC R03AC

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeR03AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009013820
30 VIAL in 1 CARTON (50090-1382-0) / 3 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

021SEF3731

ALBUTEROL SULFATE

RxCUI 142153

Orange Book

A202496

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": "50090-1382_d50406d8-cb32-45b6-be89-08fdab21fea9",
  "productndc": "50090-1382",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "202496",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.083% BASE;0.017%",
        "product_no": "001",
        "approval_date": "Oct 1, 2012"
      }
    ],
    "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": "ANDA202496",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ipratropium Bromide and Albuterol Sulfate",
  "start_marketing_date": "20121015",
  "active_numerator_strength": "2.5; .5"
}

Related drugs

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