ACITRETIN (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE
NDC 42291-086-30
Acitretin Capsules, USP
10mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
30 Capsules Rx Only

Each capsule contains 10 mg acitretin, USP.
Usual Dosage: See package insert for full prescribing information.
Store at 20°C to 25°C (68° to 77°F). See USP Controlled Room Temperature.
Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
PHARMACIST: Do not cover the LOT and EXPIRY.

Manufactured by:
Sigmapharm Laboratories, LLC
Bensalem, PA 19020
Manufactured for: AvKARE, Inc., Pulaski, TN 38478

N3 42291 08630 2

AvKARE NDC 42291-087-30
Acitretin Capsules, USP
17.5mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
30 Capsules Rx Only

Each capsule contains 17.5 mg acitretin, USP.
Usual Dosage: See package insert for full prescribing information.
Store at 20°C to 25°C (68° to 77°F). See USP Controlled Room Temperature.
Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
PHARMACIST: Do not cover the LOT and EXPIRY.

Manufactured by:
Sigmapharm Laboratories, LLC
Bensalem, PA 19020
Manufactured for: AvKARE, Inc., Pulaski, TN 38478

N3 42291 08730 9

AvKARE NDC 42291-088-30
Acitretin Capsules, USP
25mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
30 Capsules Rx Only

Each capsule contains 25 mg acitretin, USP.
Usual Dosage: See package insert for full prescribing information.
Store at 20°C to 25°C (68° to 77°F). See USP Controlled Room Temperature.
Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
PHARMACIST: Do not cover the LOT and EXPIRY.

Manufactured by:
Sigmapharm Laboratories, LLC
Bensalem, PA 19020
Manufactured for: AvKARE, Inc., Pulaski, TN 38478

N3 42291 08830 6

ACITRETIN acitretin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-086 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 SODIUM ASCORBATE MALTODEXTRIN SODIUM LAURYL SULFATE CELLULOSE, MICROCRYSTALLINE GELATIN FERRIC OXIDE YELLOW TITANIUM DIOXIDE POVIDONE

Product Characteristics Color yellow, white Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 80 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-086-30 30 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204633 10/11/2017

ACITRETIN acitretin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-087 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACITRETIN (ACITRETIN) ACITRETIN 17.5 mg

Inactive Ingredients Ingredient Name Strength SODIUM ASCORBATE MALTODEXTRIN SODIUM LAURYL SULFATE CELLULOSE, MICROCRYSTALLINE GELATIN FERRIC OXIDE RED FERRIC OXIDE YELLOW TITANIUM DIOXIDE POVIDONE

Product Characteristics Color orange Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 81 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-087-30 30 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204633 10/11/2017

ACITRETIN acitretin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-088 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 SODIUM ASCORBATE MALTODEXTRIN SODIUM LAURYL SULFATE CELLULOSE, MICROCRYSTALLINE GELATIN FERRIC OXIDE YELLOW TITANIUM DIOXIDE POVIDONE

Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 83 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-088-30 30 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204633 10/11/2017

Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE