Metformin Hydrochloride (Page 6 of 6)

Principal Display Panel — Metformin Hydrochloride Tablets USP 500mg

NDC 0440-5739-01
METFORMIN HYDROCHLORIDE TABLETS USP
500 mg
Rx only 100 Tablets

Image Label
(click image for full-size original)

Principal Display Panel — Metformin Hydrochloride Tablets USP 850mg

NDC 0440-5745-01
METFORMIN HYDROCHLORIDE TABLETS USP
850 mg
Rx Only 100 Tablets

Image Label
(click image for full-size original)

Principal Display Panel — Metformin Hydrochloide Tablets USP 1000mg

NDC 0440-5746-01
METFORMIN HYDROCHLORIDE TABLETS USP
1000 mg
Rx Only 100 Tablets

Image Label
(click image for full-size original)
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0440-5739
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15 MPA.S)
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
PROPYLENE GLYCOL
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND (round shaped biconvex) Size 11mm
Flavor Imprint Code 227
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0440-5739-00 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0440-5739-81 300 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0440-5739-85 85 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:0440-5739-90 90 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:0440-5739-92 180 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:0440-5739-01 100 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:0440-5739-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091184 03/31/2016
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0440-5745(NDC:67877-218)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 850 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15 MPA.S)
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
PROPYLENE GLYCOL
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND (round shaped biconvex) Size 13mm
Flavor Imprint Code 228
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0440-5745-00 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0440-5745-81 300 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0440-5745-85 800 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:0440-5745-90 90 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:0440-5745-92 180 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:0440-5745-01 100 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:0440-5745-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091184 03/31/2016
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0440-5746(NDC:67877-221)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15 MPA.S)
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
PROPYLENE GLYCOL
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape OVAL (oval capsule shaped biconvex) Size 19mm
Flavor Imprint Code 229;229
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0440-5746-00 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0440-5746-81 300 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0440-5746-85 800 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:0440-5746-90 90 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:0440-5746-92 180 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:0440-5746-01 100 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:0440-5746-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091184 03/31/2016
Labeler — Liberty Pharmaceuticals, Inc. (012568840)

Revised: 04/2016 Liberty Pharmaceuticals, Inc.

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