REPAGLINIDE (Page 6 of 6)

HOW SUPPLIED

Repaglinide tablets, USP, 1 mg are available in the following form: Yellow, round, biconvex tablets, debossed with “745” on one side and ‘C’ on the other side.

Bottles of 100 NDC 57664-745-88

Bottles of 500 NDC 57664-745-13

Bottles of 1000 NDC 57664-745-18

Repaglinide tablets, USP, 2 mg are available in the following form: Pink, round, biconvex tablets, debossed with “747” on one side and ‘C’ on the other side.

Bottles of 100 NDC 57664-747-88

Bottles of 500 NDC 57664-747-13

Bottles of 1000 NDC 57664-747-18

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

Distributed by: Caraco Pharmaceutical Laboratories, Ltd.

Detroit, MI 48202

Manufactured by: Sun Pharmaceutical Industries. Inc.

Cranbury, NJ 08512

Iss: 08/12

C.S. No: 5465T72

Principal Display Panel

Repaglinide Tablet

1 mg

Pouch labelPouch label

Principal Display Panel

Repaglinide Tablets, USP

Rx Only

1 mg

100 Tablets

Carton Label
(click image for full-size original)

Principal Display Panel

Repaglinide Tablets, USP

Rx Only

1 mg

500 Tablets

Bag Label
(click image for full-size original)

Principal Display Panel

Repaglinide Tablets, USP

Rx Only

1 mg

1000 Tablets

Carton Label
(click image for full-size original)

Principal Display Panel

Repaglinide Tablets, USP

Rx Only

2 mg

100 Tablets

Carton Label
(click image for full-size original)

Principal Display Panel

Repaglinide Tablets, USP

Rx Only

2 mg

500 Tablets

Carton Label
(click image for full-size original)

Principal Display Panel

Repaglinide Tablets, USP

Rx Only

2 mg

1000 Tablets

Carton Label
(click image for full-size original)
REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-745
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MEGLUMINE
CROSCARMELLOSE SODIUM
POVIDONES
POLOXAMER 181
MAGNESIUM STEARATE
SILICON DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 745;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-745-88 100 TABLET in 1 BOTTLE None
2 NDC:57664-745-13 500 TABLET in 1 BOTTLE None
3 NDC:57664-745-18 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077571 07/11/2013
REPAGLINIDE repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-747
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MEGLUMINE
CROSCARMELLOSE SODIUM
POVIDONES
POLOXAMER 181
MAGNESIUM STEARATE
SILICON DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK (PINK) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 747;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-747-88 100 TABLET in 1 BOTTLE None
2 NDC:57664-747-13 500 TABLET in 1 BOTTLE None
3 NDC:57664-747-18 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077571 07/11/2013
Labeler — Caraco Pharmaceutical Laboratories, Ltd. (146974886)
Establishment
Name Address ID/FEI Operations
Caraco Pharmaceutical Laboratories, Ltd. 146974886 MANUFACTURE (57664-745), MANUFACTURE (57664-747)

Revised: 07/2013 Caraco Pharmaceutical Laboratories, Ltd.

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