Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeR03AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8576612701
30 POUCH in 1 CARTON (85766-127-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
8576612725
1 POUCH in 1 CARTON (85766-127-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
8576612730
1 POUCH in 1 CARTON (85766-127-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
8576612760
2 POUCH in 1 CARTON (85766-127-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

021SEF3731

ALBUTEROL SULFATE

RxCUI 142153

Orange Book

A074880

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": "85766-127_5032431f-2259-7fb4-e063-6294a90ad0ff",
  "productndc": "85766-127",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "074880",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.083% BASE",
        "product_no": "001",
        "approval_date": "Sep 17, 1997"
      }
    ],
    "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": "ANDA074880",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Albuterol Sulfate",
  "start_marketing_date": "19970917",
  "active_numerator_strength": "2.5"
}

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