METFORMIN HYDROCHLORIDE - metformin hydrochloride tablet, extended release 
Zydus Lifesciences Limited

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Metformin Hydrochloride Extended-release Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-027-05 in bottle of 500 tablets

Metformin Hydrochloride Extended-release Tablets USP, 500 mg

Rx only

500 tablets

500 mg

NDC 65841-039-05 in bottle of 500 tablets

Metformin Hydrochloride Extended-release Tablets USP, 750 mg

Rx only

500 tablets

750 mg
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-027
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 63;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-027-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
2NDC:65841-027-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07706009/28/2005
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-039
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE750 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code Z;C;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-039-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
2NDC:65841-039-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07707809/28/2005
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-027, 65841-039) , MANUFACTURE(65841-027, 65841-039)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(65841-027, 65841-039) , MANUFACTURE(65841-027, 65841-039)

Revised: 11/2022
Document Id: 98157d0e-cac3-45cb-9726-e8d005a48126
Set id: a8a10ea0-7aa6-48ab-aad4-af8895636672
Version: 2
Effective Time: 20221105
 
Zydus Lifesciences Limited