Hydrochlorothiazide (Page 3 of 3)

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne,

Bardez, Goa 403 511, India

Marketed by:

Company Logo

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 12.5mgLabel 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

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