ALBUTEROL SULFATE

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeR03AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6213518923
2 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20)
ndc11
6213518924
2 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05)
ndc11
6213518941
120 mL in 1 CONTAINER (62135-189-41)
ndc11
6213518947
473 mL in 1 CONTAINER (62135-189-47)

Annotations

UNII (FDA Substance ID)

021SEF3731

ALBUTEROL SULFATE

RxCUI 142153

Orange Book

A077788

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": "ORAL",
  "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": "62135-189_316befe4-1351-2acb-e063-6394a90a9a17",
  "productndc": "62135-189",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "077788",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 2MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Jun 26, 2007"
      }
    ],
    "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/5mL",
  "application_number": "ANDA077788",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Albuterol Sulfate",
  "start_marketing_date": "20070626",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code R03AC02.

Access this data programmatically

Query ALBUTEROL SULFATE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs