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United States · US · US:60687-405_1a02568a-4fa8-5ec8-e063-6294a90a1558

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

In shortageOrange BookUNIISPLATC R03AC

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeR03AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068740583
    30 POUCH in 1 CARTON (60687-405-83) / 1 AMPULE in 1 POUCH (60687-405-79) / 3 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A202496
AN
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": "60687-405_1a02568a-4fa8-5ec8-e063-6294a90a1558",
  "productndc": "60687-405",
  "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": "20190121",
  "active_numerator_strength": "2.5; .5"
}

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