NDC 0615-8512

Labetalol Hydrochloride 100 mg tablet, film coated

On the label: NCS HealthCare of KY, Inc dba Vangard Labs. It's repackaged: NCS HealthCare of KY, Inc dba Vangard Labs rebottles it from Biocon Pharma Inc.'s NDC 70377-060.

United States: 1India: 1

Where the pills inside were made

FactoryWhereRoleLast FDA inspection
Appco Pharma LLCPiscataway, NJ, United StatesMakes it, tests it and packages it Problems found, fixed voluntarilyMay 14, 2026 · 9 inspections
Piramal Pharma LimitedPithampur, IndiaMakes it, tests it and packages it No problems foundMay 19, 2023 · 8 inspections

Repackaging site

Product details

Generic drug
Labetalol: every company that makes it
Form
tablet, film coated, oral
Strength
100 mg
Approval
ANDA ANDA209603
On the market since
May 27, 2021
Package NDCs
0615-8512-39
Official label
DailyMed (National Library of Medicine), updated Jun 21, 2024

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