Lisinopril and Hydrochlorothiazide (Page 7 of 7)

Replacement Therapy

The combination may be substituted for the titrated individual components.

Use in Renal Impairment

Regimens of therapy with lisinopril/HCTZ need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.7m² (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril/HCTZ is not recommended (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure).

HOW SUPPLIED

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.

They are supplied as follows:

NDC 68180-518-01 – 100’s bottle

NDC 68180-518-02 – 500’s bottle

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.

They are supplied as follows:

NDC 68180-519-01 – 100’s bottle

NDC 68180-519-02 – 500’s bottle

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.

They are supplied as follows:

NDC 68180-520-01 – 100’s bottle

NDC 68180-520-02 – 500’s bottle

Storage

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.

*AN69 is a registered trademark of Hospal Ltd.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

MADE IN INDIA

Revised: October 2017 ID#: 253316

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	20 mg/12.5 mg
90	71610-375-60
180	71610-375-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506
20200114JH

PRINCIPAL DISPLAY PANEL — 20 mg/ 12.5 mg

NDC 71610-375 — Lisinopril/Hydrochlorothiazide, USP 20 mg/12.5 mg Tablets — Rx Only

LISINOPRIL AND HYDROCHLOROTHIAZIDE lisinopril and hydrochlorothiazide tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-375(NDC:68180-519) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 20 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE FERRIC OXIDE YELLOW MANNITOL STARCH, CORN MAGNESIUM STEARATE

Product Characteristics Color YELLOW Score no score Shape ROUND Size 8mm Flavor Imprint Code LL;B02 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71610-375-60 90 TABLET in 1 BOTTLE None 2 NDC:71610-375-80 180 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077912 04/10/2006

Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Operations
Aphena Pharma Solutions — Tennessee, LLC		128385585	REPACK (71610-375)

Revised: 07/2021 Aphena Pharma Solutions — Tennessee, LLC