METFORMIN HCL- metformin hcl tablet, film coated 
TIME CAP LABORATORIES, INC

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TCL METFORMIN TABLETS 500MG - 850 MG & 1000 MG

HOW SUPPLIED

METFORMIN HYDROCHLORIDE TABLETS, USP 500 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "134" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.

HOW SUPPLIED

METFORMIN HYDROCHLORIDE TABLETS, USP 850 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "131" ON ONE SIDE AND PLAIN ON THE OTHER SIDE.  BOTTLES OF 100 AND 500.

HOW SUPPLIED

METFORMIN HYDROCHLORIDE TABLETS, USP 1000 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, OVAL SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "132" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.

100 ct 620R 1000 MG

100CT 620R

100 CT 621R

100CT 621R

100 CT 622R

100 CT 622R

METFORMIN HCL 
metformin hcl tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49483-620
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
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVALSize19mm
FlavorImprint Code 132
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-620-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2016
2NDC:49483-620-81180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2017
3NDC:49483-620-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2016
4NDC:49483-620-101000 in 1 PACKAGE; Type 0: Not a Combination Product06/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09088811/14/2016
METFORMIN HCL 
metformin hcl tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49483-621
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
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (WHITE TO OFF-WHITE) Scoreno score
ShapeROUNDSize13mm
FlavorImprint Code 131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-621-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2016
2NDC:49483-621-81180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2017
3NDC:49483-621-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2016
4NDC:49483-621-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09088811/14/2016
METFORMIN HCL 
metformin hcl tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49483-622
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
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (WHITE TO OFF-WHITE) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 134
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-622-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2016
2NDC:49483-622-81180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2017
3NDC:49483-622-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2016
4NDC:49483-622-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09088811/14/2016
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-620, 49483-621, 49483-622)

Revised: 12/2019
Document Id: 9af12167-4e7a-8e00-e053-2a95a90a270d
Set id: 542cec22-eeae-4704-9bb6-4176640e5ea8
Version: 5
Effective Time: 20191230
 
TIME CAP LABORATORIES, INC