NDC product

Levalbuterol

NDC 35573-445 · Burel Pharmaceuticals, LLC

Key facts

Product NDC 35573-445
Proprietary name Levalbuterol
Nonproprietary name Levalbuterol Hydrochloride
Substances LEVALBUTEROL HYDROCHLORIDE
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Burel Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA203653
Pharmacologic classes Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
Marketing start Apr 1, 2021
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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