PRINZIDE (Page 7 of 7)

Replacement Therapy

The combination may be substituted for the titrated individual components.

Use in Renal Impairment

The usual regimens of therapy with PRINZIDE need not be adjusted as long as the patient’s creatinine clearance is greater than 30 mL/min/1.73 m2 (serum creatinine approximately less than or equal to 3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so PRINZIDE is not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).

HOW SUPPLIED

No. 8439 — Tablets PRINZIDE 10-12.5, are blue, hexagon-shaped tablets with code 145 on one side and plain on the other side. Each tablet contains 10 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0145-58 unit of use bottles of 100.

No. 8247 — Tablets PRINZIDE 20-12.5, are yellow, hexagon-shaped tablets with code MSD/140 on one side and scored on the other side. Each tablet contains 20 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0140-58 unit of use bottles of 100.

Storage

Store at controlled room temperature, 15-30°C (59-86°F). Protect from excessive light and humidity.

Dispense in a well-closed container, if product package is subdivided.


Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
MERCK SHARP & DOHME LTD.
Cramlington, Northumberland, UK NE23 3JU

Copyright © 1989, 1992, 2005, 2006, 2011, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 12/2012
USPI-T-0521A1212R010

PRINCIPAL DISPLAY PANEL — Bottle Label 10-12.5

Prinzide® 10-12.5
(Lisinopril-Hydrochlorothiazide)

Manuf. for:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

by:
MERCK SHARP & DOHME LTD.
Cramlington, Northumberland, UK NE23 3JU
Made in UK

Each tablet contains 10 mg lisinopril and 12.5 mg hydrochlorothiazide.

100 Tablets

NDC 0006-0145-58

Store at controlled room temperature, 15-30°C (59-86°F). Protect from excessive light and humidity.

USUAL ADULT DOSAGE: See accompanying circular.

Rx only

7001165600100 | No. 8439

PRINCIPAL DISPLAY PANEL -- Bottle Label 10-12.5
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Bottle Label 20-12.5

Prinzide® 20-12.5
(Lisinopril-Hydrochlorothiazide)

Manuf. for:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

by:
MERCK SHARP & DOHME LTD.
Cramlington, Northumberland, UK NE23 3JU
Made in UK

Each tablet contains 20 mg lisinopril and 12.5 mg hydrochlorothiazide.

100 Tablets

NDC 0006-0140-58

Store at controlled room temperature, 15-30°C (59-86°F). Protect from excessive light and humidity.

USUAL ADULT DOSAGE: See accompanying circular.

Rx only

7001165700100 | No. 8247

PRINCIPAL DISPLAY PANEL -- Bottle Label 20-12.5
(click image for full-size original)
PRINZIDE lisinopril and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lisinopril (LISINOPRIL ANHYDROUS) lisinopril 10 mg
hydrochlorothiazide (hydrochlorothiazide) hydrochlorothiazide 12.5 mg
Inactive Ingredients
Ingredient Name Strength
calcium phosphate, dibasic, dihydrate
magnesium stearate
mannitol
starch, corn
FD&C blue no. 2
aluminum oxide
Product Characteristics
Color BLUE Score no score
Shape HEXAGON (6 SIDED) Size 6mm
Flavor Imprint Code 145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0145-58 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019778 02/16/1989
PRINZIDE lisinopril and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lisinopril (LISINOPRIL ANHYDROUS) lisinopril 20 mg
hydrochlorothiazide (hydrochlorothiazide) hydrochlorothiazide 12.5 mg
Inactive Ingredients
Ingredient Name Strength
calcium phosphate, dibasic, dihydrate
magnesium stearate
mannitol
starch, corn
ferric oxide yellow
Product Characteristics
Color YELLOW Score 2 pieces
Shape HEXAGON (6 SIDED) Size 9mm
Flavor Imprint Code MSD;140
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0140-58 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019778 02/16/1989
Labeler — Merck Sharp & Dohme Corp. (001317601)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Ltd. 212559095 MANUFACTURE (0006-0145) (0006-0140)
Establishment
Name Address ID/FEI Operations
MSD International GmbH 989517008 API MANUFACTURE (0006-0145) (0006-0140)
Establishment
Name Address ID/FEI Operations
Abic Ltd. 600000301 API MANUFACTURE (0006-0145) (0006-0140)
Establishment
Name Address ID/FEI Operations
MSD International GmbH (Puerto Rico Branch) LLC 967475786 API MANUFACTURE (0006-0145) (0006-0140)
Establishment
Name Address ID/FEI Operations
Laboratoires Merck Sharp & Dohme-Chibret 493743678 API MANUFACTURE (0006-0145) (0006-0140)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 101740835 PACK (0006-0145) (0006-0140)

Revised: 12/2012 Merck Sharp & Dohme Corp.

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