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

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

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

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

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