ALBUTEROL SULFATE

In shortageOrange BookUNIISPLATC R03AC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeR03AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166215131
1 INHALER in 1 CARTON (51662-1513-1) / 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": "51662-1513_ef7c1f9d-3076-5fc6-e053-2a95a90aafec",
  "productndc": "51662-1513",
  "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": "20200818",
  "active_numerator_strength": "90"
}

Related drugs

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