NDC Code(s) : 0179-0127-50
Packager : KAISER FOUNDATION HOSPITALS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Triamterene and HydrochlorothiazideTriamterene and Hydrochlorothiazide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0179-0127(NDC:0591-0348)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMTERENE(UNII: WS821Z52LQ)
(TRIAMTERENE - UNII:WS821Z52LQ) 		TRIAMTERENE75 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code WATSON;348
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0179-0127-5050 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071851 01/15/2013

PRINCIPAL DISPLAY PANEL

NDC 0179-0127-50
Triamterene and Hydrochlorothiazide Tablets USP
75mg/50mg
50 Tablets     Rx only

Each tablet contains:
Triamterene USP, 75 mg
Hydrochlorothiazide USP, 50 mg

Usual Dosage: See insert for full prescribing information.

Dispense in a tight, light-resistant containter wtih a
child-resistant closure.

Store at 20º-25ºC (68º-77ºF). [See USP controlled room
temperature.] Project from light.

Keep this and all medication out of the reach of children.

Manufactured By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA
Code No. GO/DRUGS/741        174377
Distributed By: Watson Pharma, Inc.

Repackaged by:
KAISER FOUNDATION HOSPITALS
Livermore, CA 94551

NDC 0179-0127-50 Triamterene and Hydrochlorothiazide Tablets USP 75mg/50mg 50 Tablets Rx only