Metformin hydrochloride tablet, film coated

Ingredients and appearance - Product information

Metformin hydrochloride tablet, film coated- Metformin hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0440-5739
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metformin hydrochloride ( UNII: 786Z46389E)( Metformin - UNII: 9100L32L2N ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Povidone ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Hypromellose 2910 (15 mpa.s) ( UNII: 36SFW2JZ0W)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color WHITE (white to off white) Imprint Code 227
Score 1 Shape ROUND (round shaped biconvex)
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0440-5739-00 1000 in 1 BOTTLE 2016/03/31
2 NDC: 0440-5739-81 300 in 1 BOTTLE 2016/03/31
3 NDC: 0440-5739-85 85 in 1 BOTTLE 2016/03/31
4 NDC: 0440-5739-90 90 in 1 BOTTLE 2016/03/31
5 NDC: 0440-5739-92 180 in 1 BOTTLE 2016/03/31
6 NDC: 0440-5739-01 100 in 1 BOTTLE 2016/03/31
7 NDC: 0440-5739-05 500 in 1 BOTTLE 2016/03/31

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091184 USA 2016/03/31

Metformin hydrochloride tablet, film coated- Metformin hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0440-5745
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metformin hydrochloride ( UNII: 786Z46389E)( Metformin - UNII: 9100L32L2N ) 850 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Povidone ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Hypromellose 2910 (15 mpa.s) ( UNII: 36SFW2JZ0W)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color WHITE (white to off white) Imprint Code 228
Score 1 Shape ROUND (round shaped biconvex)
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0440-5745-00 1000 in 1 BOTTLE 2016/03/31
2 NDC: 0440-5745-81 300 in 1 BOTTLE 2016/03/31
3 NDC: 0440-5745-85 800 in 1 BOTTLE 2016/03/31
4 NDC: 0440-5745-90 90 in 1 BOTTLE 2016/03/31
5 NDC: 0440-5745-92 180 in 1 BOTTLE 2016/03/31
6 NDC: 0440-5745-01 100 in 1 BOTTLE 2016/03/31
7 NDC: 0440-5745-05 500 in 1 BOTTLE 2016/03/31

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091184 USA 2016/03/31

Metformin hydrochloride tablet, film coated- Metformin hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0440-5746
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metformin hydrochloride ( UNII: 786Z46389E)( Metformin - UNII: 9100L32L2N ) 1000 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Povidone ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Hypromellose 2910 (15 mpa.s) ( UNII: 36SFW2JZ0W)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color WHITE (white to off white) Imprint Code 229;229
Score 2 Shape OVAL (oval capsule shaped biconvex)
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0440-5746-00 1000 in 1 BOTTLE 2016/03/31
2 NDC: 0440-5746-81 300 in 1 BOTTLE 2016/03/31
3 NDC: 0440-5746-85 800 in 1 BOTTLE 2016/03/31
4 NDC: 0440-5746-90 90 in 1 BOTTLE 2016/03/31
5 NDC: 0440-5746-92 180 in 1 BOTTLE 2016/03/31
6 NDC: 0440-5746-01 100 in 1 BOTTLE 2016/03/31
7 NDC: 0440-5746-05 500 in 1 BOTTLE 2016/03/31

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091184 USA 2016/03/31

Labeler - Liberty Pharmaceuticals, Inc.( 012568840)