Hydrochlorothiazide (Page 3 of 3)

HOW SUPPLIED

Hydrochlorothiazide Capsules, USP are #4 Teal Opaque/White Opaque two piece hard gelatin capsules imprinted with WATSON 347 and 12.5 mg in black ink. They are supplied in bottles of 100 (NDC 0591-0347-01) and 500 (NDC 0591-0347-05). Bottles of 100 are supplied with child resistant closures.

Dispense in a tight, light-resistant container as defined in the USP.

Keep out of reach of children.

Store at 20°- 25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.

Rx only

For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054 USA
1-888-838-2872

Made in India

Manufactured By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: August 2020

237496-3

PRINCIPAL DISPLAY PANEL

NDC 0591-0347-01
Hydrochlorothiazide Capsules, USP, 12.5 mg
100 Capsules
Rx only

HYDROCHLOROTHIAZIDE hydrochlorothiazide capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0347 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 SILICON DIOXIDE STARCH, CORN D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FD&C BLUE NO. 2 FD&C RED NO. 40

Product Characteristics Color white (WHITE OPAQUE) , turquoise (TEAL OPAQUE) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code WATSON;347;and;12;5;mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0591-0347-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE None 2 NDC:0591-0347-05 500 CAPSULE, GELATIN COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA020504 12/27/1996

Labeler — Actavis Pharma, Inc. (119723554)

Establishment
Name	Address	ID/FEI	Operations
Watson Pharma Private Limited		677605709	manufacture (0591-0347)

Revised: 10/2022 Actavis Pharma, Inc.