NDC Code(s) : 82619-101-01, 82619-102-01
Packager : Creekwood Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FenofibrateFenofibrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82619-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1) 		FENOFIBRATE40 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE(UNII: O03S90U1F2)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
POVIDONE K30(UNII: U725QWY32X)
CROSPOVIDONE(UNII: 2S7830E561)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 293
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:82619-101-0190 in 1 BOTTLE Type 0: Not a Combination Product20/09/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217732 09/07/2023
FenofibrateFenofibrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82619-102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1) 		FENOFIBRATE120 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE(UNII: O03S90U1F2)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
POVIDONE K30(UNII: U725QWY32X)
CROSPOVIDONE(UNII: 2S7830E561)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code 294
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:82619-102-0190 in 1 BOTTLE Type 0: Not a Combination Product20/09/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217732 09/07/2023

LABELER - Creekwood Pharmaceuticals LLC(118582565)

PRINCIPAL DISPLAY PANEL

Fenofibrate Tablets USP, 40 mg

NDC 82619-101-01 

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Fenofibrate Tablets USP, 120 mg

NDC 82619-102-01

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