NDC Code(s) : 55111-349-30, 55111-349-01, 55111-395-30, 55111-395-90, 55111-395-01
Packager : Dr. Reddy's Laboratories Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FenofibrateFenofibrate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-349
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fenofibrate(UNII: U202363UOS)
(Fenofibric Acid - UNII:BGF9MN2HU1) 		Fenofibrate43 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Ferrosoferric Oxide(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Shellac(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
RAW SUGAR(UNII: 8M707QY5GH)
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
Product Characteristics
Color GREEN (light green/white ) Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code LU;C21
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-349-3030 in 1 BOTTLE Type 0: Not a Combination Product04/07/2014
2NDC:55111-349-01100 in 1 BOTTLE Type 0: Not a Combination Product04/07/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090859 04/07/2014
FenofibrateFenofibrate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-395
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fenofibrate(UNII: U202363UOS)
(Fenofibric Acid - UNII:BGF9MN2HU1) 		Fenofibrate130 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Ferrosoferric Oxide(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Shellac(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
RAW SUGAR(UNII: 8M707QY5GH)
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
Product Characteristics
Color GREEN (dark green/white) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code LU;C22
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-395-3030 in 1 BOTTLE Type 0: Not a Combination Product04/07/2014
2NDC:55111-395-9090 in 1 BOTTLE Type 0: Not a Combination Product04/07/2014
3NDC:55111-395-01100 in 1 BOTTLE Type 0: Not a Combination Product04/07/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090859 04/07/2014

LABELER - Dr. Reddy's Laboratories Limited(650562841)

Establishment
Name Address ID/FEI Business Operations
Lupin Limited 677600414 analysis(55111-349, 55111-395), manufacture(55111-349, 55111-395)

PRINCIPAL DISPLAY PANEL

Fenofibrate Capsules USP, 43 mg - Container Label

PRINCIPAL DISPLAY PANEL

Fenofibrate Capsules USP, 130 mg - Container Label