United States · FDA National Drug Code directory

Levalbuterol

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
35573-445_0639bb69-d41d-4786-af70-797c452fbbfb
Product NDC
35573-445
Form
SOLUTION
Composition / generic term
Levalbuterol Hydrochloride
Labeler
Burel Pharmaceuticals, LLC
Marketing category
ANDA
Marketing start / end (source format)
20210401
Source listing expiry
20261231

Source-listed ingredients

  • LEVALBUTEROL HYDROCHLORIDE — 1.25 mg/3mL

These values do not establish equivalence or a dose recommendation.

Packages

  • 25 POUCH in 1 CARTON (35573-445-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE · 35573-445-25

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

Browse United States records →