Glimepiride (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-1526

NDC: 50090-1526-0 30 TABLET in a BOTTLE

NDC: 50090-1526-1 100 TABLET in a BOTTLE

NDC: 50090-1526-3 90 TABLET in a BOTTLE

NDC: 50090-1526-4 180 TABLET in a BOTTLE

Product: 50090-1987

NDC: 50090-1987-0 30 TABLET in a BOTTLE

NDC: 50090-1987-1 100 TABLET in a BOTTLE

NDC: 50090-1987-2 60 TABLET in a BOTTLE

NDC: 50090-1987-3 90 TABLET in a BOTTLE

NDC: 50090-1987-4 180 TABLET in a BOTTLE

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)].

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited, Ahmedabad -380 054, India.

10 1677 2 693003

Issued February 2019

Glimepiride

Label ImageLabel Image

Glimepiride

Label ImageLabel Image
GLIMEPIRIDE glimepiride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1526(NDC:16729-002)
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color green Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code AHI;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1526-0 30 TABLET in 1 BOTTLE None
2 NDC:50090-1526-1 100 TABLET in 1 BOTTLE None
3 NDC:50090-1526-3 90 TABLET in 1 BOTTLE None
4 NDC:50090-1526-4 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078181 08/23/2007
GLIMEPIRIDE glimepiride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1987(NDC:16729-003)
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
FD&C BLUE NO. 2
Product Characteristics
Color blue Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code AHI;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1987-0 30 TABLET in 1 BOTTLE None
2 NDC:50090-1987-1 100 TABLET in 1 BOTTLE None
3 NDC:50090-1987-2 60 TABLET in 1 BOTTLE None
4 NDC:50090-1987-3 90 TABLET in 1 BOTTLE None
5 NDC:50090-1987-4 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078181 08/23/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1526), REPACK (50090-1526), RELABEL (50090-1987)

Revised: 07/2021 A-S Medication Solutions

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