Glimepiride (Page 6 of 6)

17 PATIENT COUNSELING INFORMATION

Hypoglycemia

Explain the symptoms and treatment of hypoglycemia as well as conditions that predispose to hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia and that this may present a risk in situations where these abilities are especially important, such as driving or operating other machinery [see Warnings and Precautions (5.1)].

Hypersensitivity Reactions

Inform patients that hypersensitivity reactions may occur with glimepiride and that if a reaction occurs to seek medical treatment and discontinue glimepiride [see Warnings and Precautions (5.2)].

Pregnancy

Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise breastfeeding women taking glimepiride to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures) [see Use in Specific Populations (8.2)].

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 038, India

Revised: 01/2019

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 mg (100 Tablet Bottle)

NDC 65862-579-01

Rx only
Glimepiride Tablets, USP
1 mg
ONCE A DAY

AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2 mg (100 Tablet Bottle)

NDC 65862-580-01

Rx only
Glimepiride Tablets, USP
2 mg
ONCE A DAY

AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 4 mg (100 Tablet Bottle)

NDC 65862-581-01

Rx only
Glimepiride Tablets, USP
4 mg
ONCE A DAY

AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 4 mg (100 Tablet Bottle)
(click image for full-size original)

GLIMEPIRIDE glimepiride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-579
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIMEPIRIDE (GLIMEPIRIDE) GLIMEPIRIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K25
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL (Flat-faced, Notched Sides at Double Bisect) Size 10mm
Flavor Imprint Code X;76
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-579-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-579-05 500 TABLET in 1 BOTTLE None
3 NDC:65862-579-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202759 06/29/2012
GLIMEPIRIDE glimepiride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-580
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIMEPIRIDE (GLIMEPIRIDE) GLIMEPIRIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K25
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL (Flat-faced, Notched Sides at Double Bisect) Size 10mm
Flavor Imprint Code Y;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-580-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-580-05 500 TABLET in 1 BOTTLE None
3 NDC:65862-580-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202759 06/29/2012
GLIMEPIRIDE glimepiride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-581
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIMEPIRIDE (GLIMEPIRIDE) GLIMEPIRIDE 4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K25
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (Light Blue to Blue) Score 2 pieces
Shape OVAL (Flat-faced, Notched Sides at Double Bisect) Size 10mm
Flavor Imprint Code Y;34
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-581-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-581-25 250 TABLET in 1 BOTTLE None
3 NDC:65862-581-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-581-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202759 06/29/2012
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-579), ANALYSIS (65862-580), ANALYSIS (65862-581), MANUFACTURE (65862-579), MANUFACTURE (65862-580), MANUFACTURE (65862-581)

Revised: 09/2019 Aurobindo Pharma Limited

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