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United States · US · US:80425-0359_2a996b2b-b5da-65e7-e063-6394a90adeed

Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeR03AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8042503591
    1 INHALER in 1 CARTON (80425-0359-1) / 200 AEROSOL, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
N020983
AB3
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": "80425-0359_2a996b2b-b5da-65e7-e063-6394a90adeed",
  "productndc": "80425-0359",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "020983",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB3",
        "strength": "EQ 0.09MG BASE/INH",
        "product_no": "001",
        "approval_date": "Apr 19, 2001"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA020983",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "albuterol sulfate",
  "start_marketing_date": "20230907",
  "active_numerator_strength": "90"
}

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