NDC 33342-408

Dapagliflozin and Metformin Hydrochloride 5 mg / 1000 mg tablet, extended release

On the label: Macleods Pharmaceuticals Limited.

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Macleods Pharmaceuticals LimitedDistrict Solan, IndiaMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action

Product details

Generic drug
Dapagliflozin and Metformin: every company that makes it
Form
tablet, extended release, oral
Strength
5 mg / 1000 mg
Approval
ANDA ANDA211559
On the market since
Apr 6, 2026
Package NDCs
33342-408-06 33342-408-07 33342-408-09 33342-408-10 33342-408-15 33342-408-66
Official label
DailyMed (National Library of Medicine), updated Sep 16, 2026

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