NDC Code(s) : 0169-0093-90, 0169-0093-21, 0169-0093-01, 0169-0092-90, 0169-0092-21, 0169-0092-01
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PRANDIMETrepaglinide and metformin hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-0093
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REPAGLINIDE(UNII: 668Z8C33LU)
(REPAGLINIDE - UNII:668Z8C33LU) 		REPAGLINIDE1 mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
IRON(UNII: E1UOL152H7)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MEGLUMINE(UNII: 6HG8UB2MUY)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POLOXAMER 188(UNII: LQA7B6G8JG)
SORBITOL(UNII: 506T60A25R)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
AMMONIUM LAURETH-12 SULFATE(UNII: E1ZP93931S)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND (BICONVEX) Size 5 mm
Flavor Imprint Code 1mg;500mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-0093-901 in 1 CARTON 16/01/2009
112 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0169-0093-211 in 1 CARTON 16/01/2009
220 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:0169-0093-011 in 1 CARTON 16/01/2009
3100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022386 01/16/2009 05/31/2017
PRANDIMETrepaglinide and metformin hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-0092
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REPAGLINIDE(UNII: 668Z8C33LU)
(REPAGLINIDE - UNII:668Z8C33LU) 		REPAGLINIDE2 mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
IRON(UNII: E1UOL152H7)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MEGLUMINE(UNII: 6HG8UB2MUY)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POLOXAMER 188(UNII: LQA7B6G8JG)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SORBITOL(UNII: 506T60A25R)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
AMMONIUM LAURETH-12 SULFATE(UNII: E1ZP93931S)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND (BICONVEX) Size 5 mm
Flavor Imprint Code 2mg;500mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-0092-901 in 1 CARTON 16/01/2009
112 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0169-0092-211 in 1 CARTON 16/01/2009
220 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:0169-0092-011 in 1 CARTON 16/01/2009
3100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022386 01/15/2009 05/31/2017

PRINCIPAL DISPLAY PANEL

1 mg/500 mg Tablets

PRANDIMET

(repaglinide/metformin HCl) Tablets

1 mg/500 mg

NDC 0169-0093-01

List 009301

100 Tablets

Rx Only

Carton Display Panel - 1 mg/500 mg Tablets

PRINCIPAL DISPLAY PANEL

2 mg/500 mg Tablets

PRANDIMET

(repaglinide/metformin HCl) Tablets

2 mg/500 mg

NDC 0169-0092-01

List 009201

100 Tablets

Rx Only

Carton Display Panel - 2 mg/500 mg Tablets