Acitretin: Package Insert and Label Information (Page 6 of 6)

PRINCIPAL DISPLAY PANAL – 10 mg

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 India3012xxx 08/16

Acitretin Capsules 10 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANAL – 25 mg

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 India3012xxx 08/16

Acitretin Capsules 20 mg Bottle Label
(click image for full-size original)
ACITRETIN acitretin 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 (ACITRETIN) ACITRETIN 10 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
GELATIN, UNSPECIFIED
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE 101
POLOXAMER 407
FERRIC OXIDE RED
SODIUM ASCORBATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color ORANGE (swedish orange opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;AC;I;02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-7020-93 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202148 03/10/2016
ACITRETIN acitretin 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 (ACITRETIN) ACITRETIN 25 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
GELATIN, UNSPECIFIED
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE 101
POLOXAMER 407
FERRIC OXIDE RED
SODIUM ASCORBATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
Product Characteristics
Color BROWN (brown opaque) , YELLOW (yellow opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code MYLAN;AC;I;13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-7023-93 30 CAPSULE in 1 BOTTLE, PLASTIC None
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)

Revised: 03/2022 Mylan Pharmaceuticals Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.