METFORMIN HCL tablet, film coated

METFORMIN HCL by

Drug Labeling and Warnings

METFORMIN HCL by is a Prescription medication manufactured, distributed, or labeled by TIME CAP LABORATORIES, INC, MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

100 CT 621R

100 CT 622R

INGREDIENTS AND APPEARANCE

METFORMIN HCL 
metformin hcl tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49483-620
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	1000 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	132
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-620-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2016
2	NDC: 49483-620-81	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2017
3	NDC: 49483-620-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2016
4	NDC: 49483-620-10	1000 in 1 PACKAGE; Type 0: Not a Combination Product	06/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090888	11/14/2016

METFORMIN HCL 
metformin hcl tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49483-621
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	850 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	131
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-621-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2016
2	NDC: 49483-621-81	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2017
3	NDC: 49483-621-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2016
4	NDC: 49483-621-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090888	11/14/2016

METFORMIN HCL 
metformin hcl tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49483-622
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	134
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-622-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2016
2	NDC: 49483-622-81	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2017
3	NDC: 49483-622-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2016
4	NDC: 49483-622-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090888	11/14/2016

Labeler - TIME CAP LABORATORIES, INC (037052099)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(49483-620, 49483-621, 49483-622)