Levalbuterol

Orange BookUNIISPL

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

Identification

ManufacturerBurel Pharmaceuticals, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3557344525
25 POUCH in 1 CARTON (35573-445-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

WDQ1526QJM

LEVALBUTEROL HYDROCHLORIDE

RxCUI 237160

Orange Book

A203653

ANANAN

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WDQ1526QJM",
    "rxcui": "237160",
    "inchikey": "OWNWYCOLFIFTLK-YDALLXLXSA-N",
    "display_name": "LEVALBUTEROL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "d6998949-e1cb-4c86-a480-c0dfd9cb75b5": {
      "match": "brand_token",
      "title": "LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]",
      "spl_version": "22",
      "published_date": "2025-12-12"
    }
  },
  "productid": "35573-445_0639bb69-d41d-4786-af70-797c452fbbfb",
  "productndc": "35573-445",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "203653",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.0103% BASE",
        "product_no": "001",
        "approval_date": "Mar 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.021% BASE",
        "product_no": "002",
        "approval_date": "Mar 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.042% BASE",
        "product_no": "003",
        "approval_date": "Mar 22, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVALBUTEROL HYDROCHLORIDE",
  "proprietary_name": "Levalbuterol",
  "active_ingred_unit": "mg/3mL",
  "application_number": "ANDA203653",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levalbuterol Hydrochloride",
  "start_marketing_date": "20210401",
  "active_numerator_strength": "1.25"
}

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