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Levalbuterol

Levalbuterol Inhalation Solution, USP These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx only

Approved
Approval ID

901679b1-ba77-0ed7-e053-2a95a90a6520

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 19, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levalbuterol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68071-5027
Application NumberANDA203653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levalbuterol Hydrochloride
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 19, 2021
FDA Product Classification

INGREDIENTS (2)

LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 1.25 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT

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