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
- 68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16
- Product NDC
- 68083-111
- Form
- INJECTION, SOLUTION
- Composition / generic term
- Labetalol Hydrochloride
- Labeler
- Gland Pharma Limited
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20120419
- Source listing expiry
- 20261231
Source-listed ingredients
- LABETALOL HYDROCHLORIDE — 5 mg/mL
These values do not establish equivalence or a dose recommendation.
Packages
- 10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASS · 68083-111-01
- 10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS · 68083-111-02
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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