ALBUTEROL SULFATE

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerLuoxin Aurovitas Pharma (Chengdu) Co., Ltd.

CountryUS (United States)

ATC codeR03AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8189410402
30 POUCH in 1 CARTON (81894-104-02) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
8189410425
5 POUCH in 1 CARTON (81894-104-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
8189410430
6 POUCH in 1 CARTON (81894-104-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
8189410460
12 POUCH in 1 CARTON (81894-104-60) / 5 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

A206224

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": "81894-104_2350a61a-3c03-d0f7-e063-6394a90ab78a",
  "productndc": "81894-104",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206224",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.083% BASE",
        "product_no": "001",
        "approval_date": "Oct 17, 2017"
      }
    ],
    "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/mL",
  "application_number": "ANDA206224",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ALBUTEROL SULFATE",
  "start_marketing_date": "20171017",
  "active_numerator_strength": ".83"
}

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