Hydrochlorothiazide (Page 3 of 3)

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne,

Bardez, Goa 403 511, India

Marketed by:

Rochelle Park, NJ 07662

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

PACKAGE LABEL

Label Image for 53808-1016 12.5mg

Label Image for 12.5mg

HYDROCHLOROTHIAZIDE hydrochlorothiazide capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1016(NDC:29300-130) Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE FERROSOFERRIC OXIDE GELATIN MAGNESIUM STEARATE COLLOIDAL SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code U;130 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53808-1016-2 60 CAPSULE (CAPSULE) in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090510 11/01/2014

Labeler — State of Florida DOH Central Pharmacy (829348114)

Establishment
Name	Address	ID/FEI	Operations
State of Florida DOH Central Pharmacy		829348114	repack (53808-1016)

Revised: 01/2015 State of Florida DOH Central Pharmacy