Levalbuterol tartrate HFA inhalation

Orange BookUNIISPL

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6318787615
1 INHALER in 1 CARTON (63187-876-15) / 200 AEROSOL, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)

ADS4I3E22M

LEVALBUTEROL TARTRATE

RxCUI 487066

Orange Book

N021730

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ADS4I3E22M",
    "rxcui": "487066",
    "inchikey": "VNVNZKCCDVFGAP-FPDJQMMJSA-N",
    "display_name": "LEVALBUTEROL TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "63187-876_a790bb9c-91e9-4231-a093-4d3edbaf94fc",
  "productndc": "63187-876",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "021730",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.045MG BASE/INH",
        "product_no": "001",
        "approval_date": "Mar 11, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVALBUTEROL TARTRATE",
  "proprietary_name": "Levalbuterol tartrate HFA inhalation",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021730",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "levalbuterol tartrate",
  "start_marketing_date": "20161001",
  "active_numerator_strength": "45"
}

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