NDC Code(s) : 42291-592-18, 42291-593-18
Packager : AvKARE, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin HydrochlorideMetformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-592(NDC:68180-336)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL (OVAL) Size 18 mm
Flavor Imprint Code Q21;LU
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-592-18180 in 1 BOTTLE Type 0: Not a Combination Product12/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090692 12/04/2014
Metformin HydrochlorideMetformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-593(NDC:68180-337)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL (OVAL) Size 21 mm
Flavor Imprint Code Q22;LU
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-593-18180 in 1 BOTTLE Type 0: Not a Combination Product12/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090692 12/04/2014

PRINCIPAL DISPLAY PANEL

AvKARE

NDC 42291-592-60

Metformin Hydrochloride Extended-Release Tablets

500 mg

60 Tablets       Rx Only

Each coated extended-release tablet contains metformin hydrochloride USP 500 mg.

USUAL DOSAGE: See package insert.

WARNING: Keep out of the reach of children.

PHARMACIST:
Dispense in tight, light-resistant container as defined in USP. Extended-release tablets should not be broken, crushed, or chewed.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat and humidity.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 07/11       AV 11/14 (P)

N3   42291 59260   5

500mg

AvKARE

NDC 42291-593-60

Metformin Hydrochloride Extended-Release Tablets

1000 mg

60 Tablets       Rx Only

Each coated extended-release tablet contains metformin hydrochloride USP 1000 mg.

USUAL DOSAGE: See package insert.

WARNING: Keep out of the reach of children.

PHARMACIST:
Dispense in tight, light-resistant container as defined in USP. Extended-release tablets should not be broken, crushed, or chewed.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat and humidity.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 07/11       AV 11/14 (P)

N3   42291 59360   2

500mg