LOSARTAN POTASSIUM- losartan potassium tablet 
DirectRX

----------

LOSARTAN POTASSIUM

Boxed Warning

fetal toxicity

When pregnancy is detected, discontinue losartan potassium tablets as soon as possible.
Drugs that act directly on the rennin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity.

Description

Clinical Pharmacology

Clinical Pharmacology Continued

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

Package Label

Label

LOSARTAN POTASSIUM 
losartan potassium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-461(NDC:13668-113)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVAL (oval shaped, biconvex) Size8mm
FlavorImprint Code 25;113
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-461-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09046712/03/2015
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-461)

Revised: 12/2015
Document Id: 25fe6b18-e409-4b17-e054-00144ff8d46c
Set id: 25fe6b18-e408-4b17-e054-00144ff8d46c
Version: 1
Effective Time: 20151203
 
DirectRX