NDC Code(s) : 50090-5796-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fenofibratefenofibrate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5796(NDC:63304-449)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1) 		FENOFIBRATE145 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
XANTHAN GUM(UNII: TTV12P4NEE)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code RH38
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-5796-090 in 1 BOTTLE Type 0: Not a Combination Product13/10/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200884 06/01/2018

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-5796), REPACK(50090-5796)

PRINCIPAL DISPLAY PANEL

Label Image