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United States · US · US:47335-756_c0e6d8e4-e189-480c-8a4c-f52dda4c6dc5

Ipratropium Bromide and Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeR03AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4733575649
    6 POUCH in 1 CARTON (47335-756-49) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
  • ndc11
    4733575652
    12 POUCH in 1 CARTON (47335-756-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A207875
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": "47335-756_c0e6d8e4-e189-480c-8a4c-f52dda4c6dc5",
  "productndc": "47335-756",
  "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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