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
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
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-217-01100 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
2NDC:67877-217-05500 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
3NDC:67877-217-101000 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
4NDC:67877-217-3810 in 1 CARTON 31/01/2011
4NDC:67877-217-3310 in 1 BLISTER PACK Type 0: Not a Combination Product31/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE850 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-218-01100 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
2NDC:67877-218-05500 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
3NDC:67877-218-101000 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
4NDC:67877-218-3810 in 1 CARTON 31/01/2011
4NDC:67877-218-3310 in 1 BLISTER PACK Type 0: Not a Combination Product31/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
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
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-221-01100 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
2NDC:67877-221-05500 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
3NDC:67877-221-101000 in 1 BOTTLE Type 0: Not a Combination Product31/01/2011
4NDC:67877-221-3810 in 1 CARTON 31/01/2011
4NDC:67877-221-3310 in 1 BLISTER PACK Type 0: Not a Combination Product31/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
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
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-413-01100 in 1 BOTTLE Type 0: Not a Combination Product27/10/2018
2NDC:67877-413-05500 in 1 BOTTLE Type 0: Not a Combination Product27/10/2018
3NDC:67877-413-101000 in 1 BOTTLE Type 0: Not a Combination Product27/10/2018
4NDC:67877-413-3310 in 1 CARTON 27/10/2018
410 in 1 BLISTER PACK Type 0: Not a Combination Product27/10/2018
5NDC:67877-413-9090 in 1 BOTTLE Type 0: Not a Combination Product27/12/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE750 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-414-01100 in 1 BOTTLE Type 0: Not a Combination Product27/10/2018
2NDC:67877-414-05500 in 1 BOTTLE Type 0: Not a Combination Product27/10/2018
3NDC:67877-414-101000 in 1 BOTTLE Type 0: Not a Combination Product27/10/2018
4NDC:67877-414-3310 in 1 CARTON 27/10/2018
410 in 1 BLISTER PACK Type 0: Not a Combination Product27/10/2018
5NDC:67877-414-9090 in 1 BOTTLE Type 0: Not a Combination Product27/12/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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)

PRINCIPAL DISPLAY PANEL


NDC 67877-217-01
METFORMIN HYDROCHLORIDE TABLETS USP
500 mg 
Rx only
100 Tablets
    

metformin-ir-500mg-100tab

NDC 67877-218-01
METFORMIN HYDROCHLORIDE TABLETS USP
850 mg 
Rx Only
100 Tablets    

metformin-ir-500mg-100tab

NDC 67877-221-01
METFORMIN HYDROCHLORIDE TABLETS USP
1000 mg 
Rx Only
100 Tablets    

metformin-ir-500mg-100tab

NDC 67877-413-90
Metformin Hydrochloride Extended-release Tablets, USP
500 mg
Rx Only
90 Tablets
   metformin-ir-500mg-100tab
NDC 67877-413-01

Metformin Hydrochloride Extended-release Tablets, USP 

500 mg 

Rx Only 

100 Tablets


metformin-ir-500mg-100tab

NDC 67877-414-90
Metformin Hydrochloride Extended-release Tablets, USP
750mg
Rx Only
90 Tablets
   

metformin-ir-500mg-100tab

NDC 67877-414-01

Metformin Hydrochloride Extended-release Tablets, USP

750 mg 

Rx Only 

100 Tablets

 metformin-ir-500mg-100tab