c and titanium dioxide.
Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Patient Information has been approved by the U.S. Food and Drug Administration.
SPL UNCLASSIFIED SECTION
Manufactured by:
Cadila Healthcare Ltd.
India
Distributed by:
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
Rev.: 12/15
LOSARTAN POT 25MG TAB 30EA
INGREDIENTS AND APPEARANCE
LOSORTAN POTASSIUM
losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70786-0135(NDC:68382-135)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 8mm
Flavor Imprint Code Z;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:70786-0135-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/04/2010
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Business Operations
Unit Dose Services 831995316 REPACK(70786-0135) , RELABEL(70786-0135)
