HYDROCHLOROTHIAZIDE (Page 3 of 3)

Infants and Children

For Diuresis and For Control of Hypertension

The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS,Pediatric Use.)

HOW SUPPLIED

Hydrochlorothiazide Tablets, USP 25 mg, are peach colored, round, debossed on one side with “H” above and “2” below the bisect and plain on the other side.

Hydrochlorothiazide Tablets, USP 25 mg are supplied as follows:

Bottles of 90 NDC 51655-272-26

Dispense in a tight, light-resistant container.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Rx only

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

Image

51U000000307US04

Revised: 09/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-272-26

Label
(click image for full-size original)
HYDROCHLOROTHIAZIDE
hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-272(NDC:23155-008)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
FD&C RED NO. 40
Product Characteristics
Color orange (Peach) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code H;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-272-26 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085182 05/04/2020
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-272)

Revised: 08/2021 Northwind Pharmaceuticals, LLC

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