NDC Code(s) : 55154-4575-6, 55154-4575-4, 55154-4575-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prandinrepaglinide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4575(NDC:0169-0082)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REPAGLINIDE(UNII: 668Z8C33LU)
(REPAGLINIDE - UNII:668Z8C33LU) 		REPAGLINIDE1 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POVIDONES(UNII: FZ989GH94E)
1,2-DIMYRISTOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL))(UNII: 2847IF81RI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MEGLUMINE(UNII: 6HG8UB2MUY)
POLOXAMER 124(UNII: 1S66E28KXA)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color yellow (YELLOW) Score no score
Shape ROUND (ROUND) Size 5 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4575-4100 in 1 CARTON
1NDC:55154-4575-61 in 1 POUCH
2NDC:55154-4575-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020741 01/03/2000

PRINCIPAL DISPLAY PANEL

Prandin®

(repaglinide) Tablet

1 mg

Pouch label

PRINCIPAL DISPLAY PANEL

Prandin®

(repaglinide) Tablets

1 mg

100 Tablets

Carton Label

PRINCIPAL DISPLAY PANEL

Prandin®

(repaglinide) Tablets

1 mg

10 Tablets

Bag Label