United States · FDA National Drug Code directory

Labetalol hydrochloride

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
0591-0605_d5dfcb69-d2c4-49ca-a684-83c9e15b3b06
Product NDC
0591-0605
Form
TABLET, FILM COATED
Composition / generic term
Labetalol hydrochloride
Labeler
Actavis Pharma, Inc.
Marketing category
ANDA
Marketing start / end (source format)
19980803 / 20260930

Source-listed ingredients

  • LABETALOL HYDROCHLORIDE — 100 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-01) · 0591-0605-01
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-05) · 0591-0605-05

Source and coverage

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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.

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