LEVOTHYROXINE SODIUM- levothyroxine sodium tablet 
DirectRX

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LEVOTHYROXINE SODIUM

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Precautions section continued

Adverse Reactions

Overdosage

Dosage and Administration

Package Label

Label

LEVOTHYROXINE SODIUM 
levothyroxine sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-976(NDC:0527-1344)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS0.088 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ACACIA (UNII: 5C5403N26O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorgreen (Olive) Score2 pieces
ShapeROUNDSize7mm
FlavorImprint Code JSP;561
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-976-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2015
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(61919-976)

Revised: 12/2015
Document Id: 26042871-1fbb-5df6-e054-00144ff8d46c
Set id: 26042871-1fba-5df6-e054-00144ff8d46c
Version: 1
Effective Time: 20151203
 
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