NDC Code(s) : 68462-520-01, 68462-520-05, 68462-520-10, 68462-521-90, 68462-521-01, 68462-521-05
Packager : GLENMARK PHARMACEUTICALS INC., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

METFORMIN HYDROCHLORIDEmetformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-520
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)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
POVIDONE K30(UNII: U725QWY32X)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (oval) Size 14 mm
Flavor Imprint Code G520
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-520-01100 in 1 BOTTLE Type 0: Not a Combination Product25/11/2019
2NDC:68462-520-05500 in 1 BOTTLE Type 0: Not a Combination Product25/11/2019
3NDC:68462-520-101000 in 1 BOTTLE Type 0: Not a Combination Product25/11/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212969 11/25/2019
METFORMIN HYDROCHLORIDEmetformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-521
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)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
POVIDONE K30(UNII: U725QWY32X)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (oval) Size 20 mm
Flavor Imprint Code G521
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-521-9090 in 1 BOTTLE Type 0: Not a Combination Product25/11/2019
2NDC:68462-521-01100 in 1 BOTTLE Type 0: Not a Combination Product25/11/2019
3NDC:68462-521-05500 in 1 BOTTLE Type 0: Not a Combination Product25/11/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212969 11/25/2019

LABELER - GLENMARK PHARMACEUTICALS INC., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE(68462-520, 68462-521), ANALYSIS(68462-520, 68462-521)

PRINCIPAL DISPLAY PANEL

NDC 68462-520-01

Metformin Hydrochloride Extended Release Tablets

500 mg

Bottle Label

100 Tablets

LBL500mg100.jpg

PRINCIPAL DISPLAY PANEL

NDC 68462-521-90

Metformin Hydrochloride Extended Release Tablets

1000 mg

Bottle Label

90 Tablets

LBL1000mg90.jpg