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

10mg
(click image for full-size original)

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

17.5mg
(click image for full-size original)

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

25mg
(click image for full-size original)
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

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