NDC Code(s) : 0378-7020-93, 0378-7023-93
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acitretinacitretin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7020
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACITRETIN(UNII: LCH760E9T7)
(ACITRETIN - UNII:LCH760E9T7) 		ACITRETIN10 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
POLOXAMER 407(UNII: TUF2IVW3M2)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM ASCORBATE(UNII: S033EH8359)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color ORANGE (swedish orange opaque) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code MYLAN;AC;I;02
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7020-9330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202148 03/10/2016
Acitretinacitretin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7023
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACITRETIN(UNII: LCH760E9T7)
(ACITRETIN - UNII:LCH760E9T7) 		ACITRETIN25 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
POLOXAMER 407(UNII: TUF2IVW3M2)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM ASCORBATE(UNII: S033EH8359)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color BROWN (brown opaque), YELLOW (yellow opaque) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code MYLAN;AC;I;13
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7023-9330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202148 03/10/2016

LABELER - Mylan Pharmaceuticals Inc.(059295980)

PRINCIPAL DISPLAY PANEL

NDC 0378-7020-93

Acitretin
Capsules, USP
10 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only      30 Capsules

Each capsule contains:
Acitretin, USP      10 mg

Usual Dosage: See accompanying prescribing information.

Dispense in a tight, light-resistant container as
defined in the USP using a child-resistant closure.

Keep container tightly closed.

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

Store at 20° to 25°C (68° to 77°F). [See USP
Controlled Room Temperature.]Protect from light. Avoid exposure to high temperature and humidity after the bottle is opened.

Code No.: DD/DRUGS/DD/291

CAUSES BIRTH DEFECTS DO NOT GET PREGNANT

Mylan.com

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

RUSV7020H1

Made in India
3012xxx 08/16

CAUSES BIRTH DEFECTS DO NOT GET PREGNANT

PRINCIPAL DISPLAY PANEL

NDC 0378-7023-93

Acitretin
Capsules, USP
25 mg

PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

Rx only      30 Capsules

Each capsule contains:
Acitretin, USP      25 mg

Usual Dosage: See accompanying
prescribing information.

Dispense in a tight, light-resistant
container as defined in the USP using
a child-resistant closure.

Keep container tightly closed.

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

Store at 20° to 25°C (68° to 77°F). [SeeUSP Controlled Room Temperature.]
Protect from light. Avoid exposure tohigh temperature and humidity afterthe bottle is opened.

Code No.: DD/DRUGS/DD/291

CAUSES BIRTH DEFECTS DO NOT GET PREGNANT

Mylan.com

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

RUSV7023H1

Made in India
3012xxx 08/16

CAUSES BIRTH DEFECTS DO NOT GET PREGNANT