NDC Code 67877-414-90 - Metformin

NDC Code(s) : 67877-217-01, 67877-217-05, 67877-217-10, 67877-217-33, 67877-217-38, 67877-218-01, 67877-218-05, 67877-218-10, 67877-218-33, 67877-218-38, 67877-221-01, 67877-221-05, 67877-221-10, 67877-221-33, 67877-221-38, 67877-413-01, 67877-413-05, 67877-413-10, 67877-413-33, 67877-413-90, 67877-414-01, 67877-414-05, 67877-414-10, 67877-414-33, 67877-414-90
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED

Product Information
Product Type	Human Prescription Drug Label	Item Code (Source)	NDC:67877-217
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED(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)	Score	no score
Shape	ROUND (round shaped biconvex)	Size	11 mm
Flavor		Imprint Code	227
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67877-217-01	100 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
2	NDC:67877-217-05	500 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
3	NDC:67877-217-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
4	NDC:67877-217-38	10 in 1 CARTON	31/01/2011
4	NDC:67877-217-33	10 in 1 BLISTER PACK Type 0: Not a Combination Product	31/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091184	01/31/2011

Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED

Product Information
Product Type	Human Prescription Drug Label	Item Code (Source)	NDC:67877-218
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED(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)	Score	no score
Shape	ROUND (round shaped biconvex)	Size	13 mm
Flavor		Imprint Code	228
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67877-218-01	100 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
2	NDC:67877-218-05	500 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
3	NDC:67877-218-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
4	NDC:67877-218-38	10 in 1 CARTON	31/01/2011
4	NDC:67877-218-33	10 in 1 BLISTER PACK Type 0: Not a Combination Product	31/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091184	01/31/2011

Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED

Product Information
Product Type	Human Prescription Drug Label	Item Code (Source)	NDC:67877-221
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED(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)	Score	2 pieces
Shape	OVAL (oval capsule shaped biconvex)	Size	19 mm
Flavor		Imprint Code	229;229
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67877-221-01	100 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
2	NDC:67877-221-05	500 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
3	NDC:67877-221-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	31/01/2011
4	NDC:67877-221-38	10 in 1 CARTON	31/01/2011
4	NDC:67877-221-33	10 in 1 BLISTER PACK Type 0: Not a Combination Product	31/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091184	01/31/2011

Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE

Product Information
Product Type	Human Prescription Drug Label	Item Code (Source)	NDC:67877-413
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (white to off white)	Score	no score
Shape	OVAL (oval shaped biconvex)	Size	19 mm
Flavor		Imprint Code	MX;500
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67877-413-01	100 in 1 BOTTLE Type 0: Not a Combination Product	27/10/2018
2	NDC:67877-413-05	500 in 1 BOTTLE Type 0: Not a Combination Product	27/10/2018
3	NDC:67877-413-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	27/10/2018
4	NDC:67877-413-33	10 in 1 CARTON	27/10/2018
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	27/10/2018
5	NDC:67877-413-90	90 in 1 BOTTLE Type 0: Not a Combination Product	27/12/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206145	10/27/2018

Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE

Product Information
Product Type	Human Prescription Drug Label	Item Code (Source)	NDC:67877-414
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	750 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (white to off white)	Score	no score
Shape	OVAL (capsule shaped tablets)	Size	21 mm
Flavor		Imprint Code	MX;750
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67877-414-01	100 in 1 BOTTLE Type 0: Not a Combination Product	27/10/2018
2	NDC:67877-414-05	500 in 1 BOTTLE Type 0: Not a Combination Product	27/10/2018
3	NDC:67877-414-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	27/10/2018
4	NDC:67877-414-33	10 in 1 CARTON	27/10/2018
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	27/10/2018
5	NDC:67877-414-90	90 in 1 BOTTLE Type 0: Not a Combination Product	27/12/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206145	10/27/2018

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name	Address	ID/FEI	Business Operations
Alkem Laboratories Limited		677605851	MANUFACTURE(67877-217, 67877-218, 67877-221, 67877-413, 67877-414)

Establishment
Name	Address	ID/FEI	Business Operations
Alkem Laboratories Limited		915628612	MANUFACTURE(67877-217, 67877-218, 67877-221)

NDC 67877-414-90
API & Excipient Details

Metformin marketed by Ascend Laboratories, LLC under NDC Code 67877-414-90

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 67877-414-90 API & Excipient Details

Metformin marketed by Ascend Laboratories, LLC under NDC Code 67877-414-90

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 67877-414-90
API & Excipient Details