GLYBURIDE- glyburide tablet 
DirectRX

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GLYBURIDE

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

Package Label

Label

GLYBURIDE 
glyburide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-378(NDC:23155-058)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC) GLYBURIDE5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code I37
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-378-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09093712/03/2015
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-378)

Revised: 12/2015
Document Id: 2615ee96-7a3e-5cde-e054-00144ff8d46c
Set id: 2615ee96-7a3d-5cde-e054-00144ff8d46c
Version: 1
Effective Time: 20151204
 
DirectRX