Metformin Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500

NDC 24724-014-01

Rx only

Metformin Hydrochloride Tablets, USP

500 mg

100 Tablets

Metformin500mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 1000

NDC 24724-016-01
Rx only
Metformin Hydrochloride Tablets, USP
1000 mg 100 Tablets

labelmet1000
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 850

NDC 24724-015-01
Rx only
Metformin Hydrochloride Tablets, USP
850 mg 100 Tablets

labelmet850
(click image for full-size original)
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24724-014
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
TALC
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code I45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24724-014-50 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:24724-014-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079148 06/03/2009
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24724-015
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
TALC
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code I46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24724-015-50 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:24724-015-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079148 06/03/2009
METFORMIN HYDROCHLORIDE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24724-016
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
TALC
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code I;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24724-016-50 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:24724-016-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079148 06/03/2009
Labeler — INDICUS PHARMA LLC (793870606)
Registrant — INDICUS PHARMA LLC (793870606)
Establishment
Name Address ID/FEI Operations
USV Private Limited 650434348 MANUFACTURE (24724-014), MANUFACTURE (24724-015), MANUFACTURE (24724-016)

Revised: 12/2020 INDICUS PHARMA LLC

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