Levalbuterol

Orange BookUNIISPL

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

Identification

ManufacturerRitedose Pharmaceuticals, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7620480001
30 POUCH in 1 CARTON (76204-800-01) / 1 AMPULE in 1 POUCH (76204-800-11) / 3 mL in 1 AMPULE
ndc11
7620480025
1 POUCH in 1 CARTON (76204-800-25) / 25 AMPULE in 1 POUCH (76204-800-15) / 3 mL in 1 AMPULE
ndc11
7620480055
5 POUCH in 1 CARTON (76204-800-55) / 5 AMPULE in 1 POUCH (76204-800-05) / 3 mL in 1 AMPULE

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": "76204-800_459fa0f5-35d9-d6e5-e063-6394a90a6f14",
  "productndc": "76204-800",
  "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": "20160322",
  "active_numerator_strength": ".63"
}

Access this data programmatically

Query Levalbuterol 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