Data / Drug companies / Labetalol hydrochloride

Labetalol hydrochloride: 43 companies and 140 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Labetalol hydrochloride is listed in the FDA National Drug Code Directory by 43 companies, with 140 products in commercial distribution. 135 of the products (96.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet; injection, and the newest product started marketing on October 19, 2026.

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Companies listing it

43

Products

140

Generic (ANDA) products

135 (96.4%)

Application numbers

20

Routes

Oral, Intravenous

Brand names

Labetalol HCl in Sodium Chloride, Labetalol HCl in Dextrose, Labetalol HCL

openFDA record search

api.fda.gov

Companies that list labetalol hydrochloride

Ranked by number of products. Finished drugs in commercial distribution.

Dosage forms

Marketing categories

Pharmacologic classes

CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.