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
- 68001-383_53bd2b04-9eae-6b4f-e063-6394a90a0751
- Product NDC
- 68001-383
- Form
- TABLET, FILM COATED
- Composition / generic term
- Labetalol Hydrochloride
- Labeler
- BluePoint Laboratories Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20190218
- Source listing expiry
- 20271231
Source-listed ingredients
- LABETALOL HYDROCHLORIDE — 300 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 100 TABLET, FILM COATED in 1 BOTTLE (68001-383-00) · 68001-383-00
- 500 TABLET, FILM COATED in 1 BOTTLE (68001-383-03) · 68001-383-03
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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