Metformin (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-500mg-60ct

500mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1000mg-60ct

1000mg
(click image for full-size original)

METFORMIN
metformin tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-633
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
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
MAGNESIUM STEARATE
POVIDONE
TRIETHYL CITRATE
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE (or off white) Score no score
Shape OVAL (biconvex) Size 16mm
Flavor Imprint Code NL2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-633-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:50742-633-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:50742-633-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209674 12/10/2018
METFORMIN
metformin tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-634
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
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
MAGNESIUM STEARATE
POVIDONE
TRIETHYL CITRATE
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE (or off white) Score no score
Shape OVAL (biconvex) Size 21mm
Flavor Imprint Code NL1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-634-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:50742-634-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:50742-634-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209674 12/10/2018
Labeler — Ingenus Pharmaceuticals, LLC (833250017)
Registrant — Novast Laboratories, Ltd. (527695995)
Establishment
Name Address ID/FEI Operations
Novast Laboratories, Ltd. 527695995 analysis (50742-633), analysis (50742-634), label (50742-633), label (50742-634), manufacture (50742-633), manufacture (50742-634), pack (50742-633), pack (50742-634)

Revised: 10/2023 Ingenus Pharmaceuticals, LLC

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