NDC 67046-433
Lisinopril and Hydrochlorothiazide 20 mg / 12.5 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-519.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Pithampur, India | Makes it and packages it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
| Lupin Limited | Nagpur, India | Makes it and packages it | Problems found, fixed voluntarilyJul 11, 2023 · 4 inspections |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Jun 20, 2025 · Class II · Lupin Pharmaceuticals Inc.
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Lots: Lot #: QA01081, Exp. Date April 2027 - Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots: Batch Q101699, Q101981 - Jul 19, 2019 · Class II · Lupin Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Lots: Lot #:H801815, Exp. March 2021 - Jul 17, 2019 · Class II · Lupin Pharmaceuticals Inc.
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Lots: Batch# H900575, exp. date 01/2022 - Apr 4, 2016 · Class III · Lupin Pharmaceuticals Inc.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Lot #: a) H303459, b) H303460, Exp 09/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydrochlorothiazide and Lisinopril: every company that makes it
- Form
- tablet
- Strength
- 20 mg / 12.5 mg
- Approval
- ANDA ANDA077912
- On the market since
- Sep 27, 2017
- Package NDCs
67046-433-0767046-433-1467046-433-1567046-433-2067046-433-2167046-433-2867046-433-3067046-433-60- Official label
- DailyMed (National Library of Medicine), updated Sep 27, 2017
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