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United States · US · US:69097-173_914605d4-7326-445d-b20e-6771eb67f7c4

Ipratropium Bromide and Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeR03AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6909717353
    6 POUCH in 1 CARTON (69097-173-53) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
  • ndc11
    6909717364
    12 POUCH in 1 CARTON (69097-173-64) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A077559
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": "69097-173_914605d4-7326-445d-b20e-6771eb67f7c4",
  "productndc": "69097-173",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "077559",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.083% BASE;0.017%",
        "product_no": "001",
        "approval_date": "Dec 31, 2007"
      }
    ],
    "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": "ANDA077559",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ipratropium Bromide and Albuterol Sulfate",
  "start_marketing_date": "20071231",
  "active_numerator_strength": "2.5; .5"
}

Related drugs

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