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United States · US · US:0093-3174_d9fc7dd4-8c8c-4c83-a6b7-02d984f4135b

Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeR03AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093317431
    1 INHALER in 1 CARTON (0093-3174-31) / 200 AEROSOL, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
N021457
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": "0093-3174_d9fc7dd4-8c8c-4c83-a6b7-02d984f4135b",
  "productndc": "0093-3174",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "021457",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "EQ 0.09MG BASE/INH",
        "product_no": "001",
        "approval_date": "Oct 29, 2004"
      }
    ],
    "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": "NDA021457",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Albuterol Sulfate",
  "start_marketing_date": "20190116",
  "active_numerator_strength": "90"
}

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