METFORMIN HCL

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

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
(click image for full-size original)

100 CT 621R

100CT 621R
(click image for full-size original)

100 CT 622R

100 CT 622R
(click image for full-size original)

METFORMIN HCL
metformin hcl tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-620
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:49483-620-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:49483-620-81 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:49483-620-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:49483-620-10 1000 TABLET, FILM COATED in 1 PACKAGE None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 850 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:49483-621-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:49483-621-81 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:49483-621-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:49483-621-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:49483-622-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:49483-622-81 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:49483-622-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:49483-622-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
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 Operations
MARKSANS PHARMA LIMITED 925822975 manufacture (49483-620), manufacture (49483-621), manufacture (49483-622)

Revised: 12/2019 TIME CAP LABORATORIES, INC

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