Repaglinide (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Repaglinide Tablets USP, 0.5 mg are white to off white, round, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘10’ on other side.
Bottles of 100 NDC 57237-157-01
Bottles of 500 NDC 57237-157-05

Repaglinide Tablets USP, 1 mg are yellow colored, round, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘11’ on other side.
Bottles of 100 NDC 57237-158-01
Bottles of 500 NDC 57237-158-05

Repaglinide Tablets USP, 2 mg are peach colored, mottled round, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘12’ on other side.
Bottles of 100 NDC 57237-159-01
Bottles of 500 NDC 57237-159-05

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture. Keep bottles tightly closed.
Dispense in tight containers with safety closures.

17 PATIENT COUNSELING INFORMATION

Hypoglycemia

Inform patients that repaglinide tablets can cause hypoglycemia and instruct patients and their caregivers on self-management procedures including glucose monitoring and management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended [see Warnings and Precautions (5.1)].

Administration

Instruct patients to take repaglinide tablet within 30 minutes before meals. Instruct patients to skip their dose of repaglinide tablet when a meal is skipped. [see Dosage and Administration (2)].

Drug Interactions

Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with repaglinide tablets. [see Drug Interactions (7)].
Distributed by:
Rising Health, LLC
Saddle Brook, NJ 07663
Made in India

Code: TS/DRUGS/19/1993
Revised: 07/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.5 mg (100 Tablet Bottle)

Rising® NDC 57237-157-01
Repaglinide
Tablets, USP
0.5 mg 100 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.5 mg (100 Tablet Bottle)
(click image for full-size original)

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

Rising® NDC 57237-158-01
Repaglinide
Tablets, USP
1 mg
100 Tablets Rx only

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)

Rising® NDC 57237-159-01
Repaglinide
Tablets, USP
2 mg
100 Tablets Rx only

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

REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REPAGLINIDE (REPAGLINIDE) REPAGLINIDE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
STARCH, CORN
GLYCERIN
MAGNESIUM STEARATE
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POLOXAMER 188
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE (White to Off White) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code H;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-157-01 100 TABLET in 1 BOTTLE None
2 NDC:57237-157-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203820 01/22/2014
REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REPAGLINIDE (REPAGLINIDE) REPAGLINIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
STARCH, CORN
GLYCERIN
MAGNESIUM STEARATE
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POLOXAMER 188
POVIDONE, UNSPECIFIED
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code H;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-158-01 100 TABLET in 1 BOTTLE None
2 NDC:57237-158-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203820 01/22/2014
REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-159
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REPAGLINIDE (REPAGLINIDE) REPAGLINIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
STARCH, CORN
GLYCERIN
MAGNESIUM STEARATE
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POLOXAMER 188
POVIDONE, UNSPECIFIED
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (Peach) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code H;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-159-01 100 TABLET in 1 BOTTLE None
2 NDC:57237-159-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203820 01/22/2014
Labeler — Rising Health, LLC (080500961)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (57237-157), ANALYSIS (57237-158), ANALYSIS (57237-159), MANUFACTURE (57237-157), MANUFACTURE (57237-158), MANUFACTURE (57237-159)

Revised: 07/2021 Rising Health, LLC

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