METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet, film coated 
Cadila Healthcare Limited

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METFORMIN HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-028-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 500 mg

Rx only

100 tablets

Image

NDC 65841-809-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 500 mg

Rx only

100 tablets

Image

NDC 65841-029-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 850 mg

Rx only

100 tablets

Image

NDC 65841-810-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 850 mg

Rx only

100 tablets

Image

NDC 65841-030-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 1000 mg

Rx only

100 tablets

Image

NDC 65841-811-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 1000 mg

Rx only

100 tablets

Image
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-028
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
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size13mm
FlavorImprint Code 70;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-028-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
2NDC:65841-028-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
3NDC:65841-028-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
4NDC:65841-028-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
5NDC:65841-028-77100 in 1 CARTON09/28/2005
5NDC:65841-028-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07706409/28/2005
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-029
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE850 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code 69;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-029-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
2NDC:65841-029-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
3NDC:65841-029-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
4NDC:65841-029-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
5NDC:65841-029-77100 in 1 CARTON09/28/2005
5NDC:65841-029-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07706409/28/2005
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code Z;71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-030-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
2NDC:65841-030-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
3NDC:65841-030-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
4NDC:65841-030-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
5NDC:65841-030-77100 in 1 CARTON09/28/2005
5NDC:65841-030-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07706409/28/2005
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-809
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
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size13mm
FlavorImprint Code 70;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-809-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
2NDC:65841-809-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
3NDC:65841-809-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
4NDC:65841-809-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
5NDC:65841-809-77100 in 1 CARTON12/09/2014
5NDC:65841-809-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20368612/09/2014
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-810
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE850 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code 69;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-810-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
2NDC:65841-810-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
3NDC:65841-810-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
4NDC:65841-810-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
5NDC:65841-810-77100 in 1 CARTON12/09/2014
5NDC:65841-810-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20368612/09/2014
METFORMIN HYDROCHLORIDE 
metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-811
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code Z;71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-811-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
2NDC:65841-811-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
3NDC:65841-811-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
4NDC:65841-811-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
5NDC:65841-811-77100 in 1 CARTON12/09/2014
5NDC:65841-811-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20368612/09/2014
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811)

Revised: 9/2020
Document Id: 39fa1b17-1eb9-425b-9d28-16a2d61ae129
Set id: 5043d03e-3c9d-4c96-b48d-187f02a1d27c
Version: 9
Effective Time: 20200901
 
Cadila Healthcare Limited