Metformin hydrochloride tablet, film coated

Repackaging information

Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 500mg 800mg 1000mg
30 43353-340-30 - 43353-349-30
45 - - 43353-349-45
60 43353-340-53 43353-344-53 43353-349-53
90 43353-340-60 43353-344-60 43353-349-60
120 43353-340-70 - -
135 - - 43353-349-73
150 43353-340-75 - -
180 43353-340-80 43353-344-80 43353-349-80
225 - - 43353-349-86
270 43353-340-92 43353-344-92 -
360 43353-340-94 - -
450 43353-340-96 - -

Store between 20-25C (68-77F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20140625SC

Ingredients and appearance - Product information

Metformin hydrochloride tablet, film coated- Metformin hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43353-340
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
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Povidones ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Starch, corn ( UNII: O8232NY3SJ)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE Imprint Code GP124
Score 1 Shape ROUND
Size 11 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075985 USA

Metformin hydrochloride tablet, film coated- Metformin hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43353-344
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
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Povidones ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Starch, corn ( UNII: O8232NY3SJ)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE Imprint Code GP127
Score 1 Shape ROUND
Size 13 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075985 USA

Metformin hydrochloride tablet, film coated- Metformin hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43353-349
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
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Povidones ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Starch, corn ( UNII: O8232NY3SJ)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE Imprint Code GP128
Score 2 Shape OVAL
Size 19 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075985 USA

Labeler - Aphena Pharma Solutions - Tennessee, LLC( 128385585)

Establishment

Name ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 Repack( 43353-340, 43353-344, 43353-349)
All doses given fasting except the first 18 doses of the multiple dose studies;
Peak plasma concentration;
Time to peak plasma concentration;
Combined results (average means) of five studies: mean age 32 years (range 23 to 59 years).
Kinetic study done following dose 19, given fasting.
Elderly subjects, mean age 71 years (range 65 to 81 years).
CLcr = creatinine clearance normalized to body surface area of 1.73 m2.
All patients on diet therapy at Baseline
Not statistically significant
All patients on glyburide, 20 mg/day, at Baseline
Not statistically significant
Statistically significant using analysis of covariance with baseline as covariate (p=0.04). Not significant using analysis of variance (values shown in table)
Statistically significant for insulin (p=0.04)
Pediatric patients mean age 13.8 years (range 10 to 16 years)
All patients on diet therapy at Baseline
Not statistically significant
Reactions that were more common in metformin- than placebo-treated patients.