NDC Code(s) : 51079-195-01, 51079-195-03, 51079-196-01, 51079-196-03
Packager : Mylan Institutional Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fenofibric Acidfenofibric acid CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-195
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRIC ACID(UNII: BGF9MN2HU1)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1) 		FENOFIBRIC ACID45 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POVIDONES(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color BROWN (brown-pink opaque), YELLOW (light yellow opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code MYLAN;CF;45
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-195-0330 in 1 BOX, UNIT-DOSE
1NDC:51079-195-011 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200913 11/21/2013
Fenofibric Acidfenofibric acid CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-196
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRIC ACID(UNII: BGF9MN2HU1)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1) 		FENOFIBRIC ACID135 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POVIDONES(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color BLUE (powder blue opaque), YELLOW (light yellow opaque) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code MYLAN;CF;135
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-196-0330 in 1 BOX, UNIT-DOSE
1NDC:51079-196-011 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200913 11/21/2013

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 45 mg

NDC 51079-195-03

Fenofibric Acid
Delayed-release
Capsules
45 mg*

30 Capsules (3 x 10)

*Each capsule contains choline
fenofibrate equivalent to 45 mg
of fenofibric acid.

Usual Dosage: See accompanying
prescribing information and Medication
Guide.

Swallow whole. Do not open,
crush, dissolve or chew capsules.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-12011

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.


Fenofibric Acid D.R. 45 mg Capsules Unit Carton LabelFenofibric Acid D.R. 45 mg Capsules Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 135 mg

NDC 51079-196-03

Fenofibric Acid
Delayed-release
Capsules
135 mg*

30 Capsules (3 x 10)

*Each capsule contains choline
fenofibrate equivalent to 135 mg
of fenofibric acid.

Usual Dosage: See accompanying
prescribing information and Medication
Guide.

Swallow whole. Do not open,
crush, dissolve or chew capsules.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-12012

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Fenofibric Acid D.R. 135 mg Capsules Unit Carton LabelFenofibric Acid D.R. 135 mg Capsules Unit Carton Label