Levalbuterol Inhalation Solution

Orange BookUNIISPL

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4733574601
5 POUCH in 1 CARTON (47335-746-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
4733574649
2 POUCH in 1 CARTON (47335-746-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ndc11
4733574652
6 POUCH in 1 CARTON (47335-746-52) / 5 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

A207820

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": "47335-746_f264b091-1414-4e44-abae-d0b787c94397",
  "productndc": "47335-746",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "207820",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.0103% BASE",
        "product_no": "001",
        "approval_date": "Nov 5, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.021% BASE",
        "product_no": "002",
        "approval_date": "Nov 5, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.042% BASE",
        "product_no": "003",
        "approval_date": "Nov 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVALBUTEROL HYDROCHLORIDE",
  "proprietary_name": "Levalbuterol Inhalation Solution",
  "active_ingred_unit": "mg/3mL",
  "application_number": "ANDA207820",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levalbuterol Inhalation Solution",
  "start_marketing_date": "20181201",
  "active_numerator_strength": ".63"
}

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