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United States · US · US:71205-441_539823ee-064c-4094-a74c-b50a07a80bf2

albuterol sulfate

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR03AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7120544185
    1 INHALER in 1 CARTON (71205-441-85) / 200 AEROSOL, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A203760
AB2
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": {
    "b0a5da99-6553-4088-ae27-7fa194438340": {
      "match": "brand_token",
      "title": "ALBUTEROL SULFATE INHALANT [AMERICAN HEALTH PACKAGING]",
      "spl_version": "3",
      "published_date": "2026-05-21"
    }
  },
  "productid": "71205-441_539823ee-064c-4094-a74c-b50a07a80bf2",
  "productndc": "71205-441",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "203760",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "EQ 0.09MG BASE/INH",
        "product_no": "001",
        "approval_date": "Feb 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBUTEROL SULFATE",
  "shortage_reason": "Albuterol Sulfate Solution",
  "shortage_status": "current",
  "proprietary_name": "albuterol sulfate",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA203760",
  "marketing_category": "ANDA",
  "nonproprietary_name": "albuterol sulfate",
  "start_marketing_date": "20200226",
  "active_numerator_strength": "90"
}

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