Hydrochlorothiazide (Page 3 of 3)

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 62135-448-90

Bottles of 500 NDC 62135-448-05

Hydrochlorothiazide Tablets, USP 50 mg, are peach colored, round, debossed on one side with “H” above and “3” below the bisect and plain on the other side.

Hydrochlorothiazide Tablets, USP 50 mg are supplied as follows:

Bottles of 90 NDC 62135-449-90

Bottles of 500 NDC 62135-449-05

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
Manufactured for:
Chartwell RX, LLC.

Congers, NY 10920

L71227

Revised 01/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrochlorothiazide Tablets, USP 25 mg — NDC-62135-448-90-90s-Bottle Label

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Hydrochlorothiazide Tablets, USP 25 mg — NDC-62135-448-05-500s-Bottle Label

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Hydrochlorothiazide Tablets, USP 50 mg — NDC-62135-449-90-90s-Bottle Label

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Hydrochlorothiazide Tablets, USP 50 mg — NDC-62135-449-05-500s-Bottle Label

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HYDROCHLOROTHIAZIDE
hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-448
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:62135-448-90 90 TABLET in 1 BOTTLE None
2 NDC:62135-448-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085182 01/15/2015
HYDROCHLOROTHIAZIDE
hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-449
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 50 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 8mm
Flavor Imprint Code H;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-449-90 90 TABLET in 1 BOTTLE None
2 NDC:62135-449-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085182 01/15/2015
Labeler — Chartwell RX, LLC (079394054)

Revised: 01/2023 Chartwell RX, LLC

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