Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeR03AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378705852
5 POUCH in 1 CARTON (0378-7058-52) / 5 VIAL in 1 POUCH (0378-7058-98) / 3 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

021SEF3731

ALBUTEROL SULFATE

RxCUI 142153

Orange Book

A214531

ANAN

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": "0378-7058_de8e18d1-bd6b-484a-a7b4-3c286c8ae917",
  "productndc": "0378-7058",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214531",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.021% BASE",
        "product_no": "001",
        "approval_date": "Dec 28, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.042% BASE",
        "product_no": "002",
        "approval_date": "Dec 28, 2021"
      }
    ],
    "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": "mg/3mL",
  "application_number": "ANDA214531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Albuterol Sulfate",
  "start_marketing_date": "20221007",
  "active_numerator_strength": "1.25"
}

Related drugs

Other records sharing ATC code R03AC02.

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