Repaglinide (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Repaglinide Tablets, USP are supplied as round tablets with beveled edges on both sides available in 0.5 mg (white, debossed with “P240” on one side), 1 mg (yellow, debossed with “P241” on one side) and 2 mg (pink, debossed with “P242” on one side) strengths.

0.5 mg tablets (white)
Bottles of 100
NDC 0574-0240-01

Bottles of 500

NDC 0574-0240-05

Bottles of 1000

NDC 0574-0240-10
1 mg tablets (yellow)
Bottles of 100
NDC 0574-0241-01

Bottles of 500

NDC 0574-0241-05

Bottles of 1000

NDC 0574-0241-10
2 mg tablets (pink)
Bottles of 100
NDC 0574-0242-01

Bottles of 500

NDC 0574-0242-05

Bottles of 1000

NDC 0574-0242-10

Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].

Protect from moisture. Keep bottles tightly close.

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 tablets within 30 minutes before meals. Instruct patients to skip their dose of repaglinide tablets 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)].

Manufactured By

Perrigo®

Minneapolis, MN 55427

2203658

8Z400 RC J4

Rev 12-19 C

PRINCIPAL DISPLAY PANEL – 0.5 mg Tablet Bottle Label

Rx Only

NDC 0574-0240 -05

Repaglinide
Tablets, USP 0.5 mg

500 Tablets

8Z4RC-repaglinide-tablets-.5mg.jpg
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

//medlibrary.org/lib/images-rx/repaglinide-2/serialization-template-300x88.jpg
(click image for full-size original)
8Z4RC-repaglinide-tablets-.5mg.jpgserialization-template.jpg

PRINCIPAL DISPLAY PANEL — 1 mg Tablet Bottle Label

Rx Only

NDC 0574-0241 -05

Repaglinide
Tablets, USP 1 mg

500 Tablets

//medlibrary.org/lib/images-rx/repaglinide-2/2r1rc-repaglinide-tablets-1mg-300x77.jpg
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

http://medlibrary.org/lib/images-rx/repaglinide-2/serialization-template.jpg
(click image for full-size original)
2R1RC-repaglinide-tablets-1mg.jpgserialization-template.jpg

PRINCIPAL DISPLAY PANEL — 2 mg Tablet Bottle Label

Rx Only

NDC 0574-0242 -05

Repaglinide
Tablets, USP 2 mg

500 Tablets

//medlibrary.org/lib/images-rx/repaglinide-2/3h6rc-repaglinide-tablets-2mg-300x78.jpg
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

http://medlibrary.org/lib/images-rx/repaglinide-2/serialization-template.jpg
(click image for full-size original)
3H6RC-repaglinide-tablets-2mg.jpgserialization-template.jpg
REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0240
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POLACRILIN POTASSIUM
POVIDONE
GLYCERIN
MAGNESIUM STEARATE
MEGLUMINE
POLOXAMER 407
SILICON DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code P240
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0240-01 100 TABLET in 1 BOTTLE None
2 NDC:0574-0240-05 500 TABLET in 1 BOTTLE None
3 NDC:0574-0240-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201189 08/09/2013
REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0241
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POLACRILIN POTASSIUM
POVIDONE
GLYCERIN
MAGNESIUM STEARATE
MEGLUMINE
POLOXAMER 407
SILICON DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code P241
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0241-01 100 TABLET in 1 BOTTLE None
2 NDC:0574-0241-05 500 TABLET in 1 BOTTLE None
3 NDC:0574-0241-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201189 01/22/2014
REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0242
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POLACRILIN POTASSIUM
POVIDONE
GLYCERIN
MAGNESIUM STEARATE
MEGLUMINE
POLOXAMER 407
SILICON DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code P242
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0242-01 100 TABLET in 1 BOTTLE None
2 NDC:0574-0242-05 500 TABLET in 1 BOTTLE None
3 NDC:0574-0242-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201189 01/22/2014
Labeler — Paddock Laboratories, LLC (967694121)

Revised: 12/2019 Paddock Laboratories, LLC

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