LEVOTHYROXINE SODIUM- levothyroxine sodium tablet 
DirectRX

----------

LEVOTHYROXINE SODIUM

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Precautions continued

Adverse Reactions

Overdosage

Dosage and Administration

Package Label

Label

LEVOTHYROXINE SODIUM 
levothyroxine sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-403(NDC:0527-1342)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS0.05 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ACACIA (UNII: 5C5403N26O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
LACTOSE (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code JSP;514
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-403-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02121012/02/2015
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-403)

Revised: 12/2015
Document Id: 26053cc7-eb22-6f0a-e054-00144ff88e88
Set id: 26053cc7-eb21-6f0a-e054-00144ff88e88
Version: 1
Effective Time: 20151203
 
DirectRX