NDC 54868-5773

Carvedilol 12.5 mg tablet, film coated

On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-144.

India: 2

Where the pills inside were made

FactoryWhereRoleLast FDA inspection
Apl Healthcare LimitedMahabubnagar, IndiaMakes it and tests it No problems foundJan 18, 2023 · 2 inspections
Aurobindo Pharma LimitedMedchal, IndiaMakes it and tests it Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug
Carvedilol: every company that makes it
Form
tablet, film coated
Strength
12.5 mg
Approval
ANDA ANDA078332
On the market since
Aug 12, 2009
Package NDCs
54868-5773-0 54868-5773-1 54868-5773-2 54868-5773-3
Official label
DailyMed (National Library of Medicine), updated Jan 18, 2012

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