Isotretinoin (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2433-15

Isotretinoin Capsules, USP

10 mg

Each capsule contains 10 mg isotretinoin, USP

Attention Pharmacist: Dispense with enclosed Medication Guide

CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

Rx only30 Capsules (3 x 10 Prescription Packs)

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2434-15

Isotretinoin Capsules, USP

20 mg

Each capsule contains 20 mg isotretinoin, USP

Attention Pharmacist: Dispense with enclosed Medication Guide

CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

Rx only30 Capsules (3 x 10 Prescription Packs)

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2451-15

Isotretinoin Capsules, USP

25 mg

Each capsule contains 25 mg isotretinoin, USP

Attention Pharmacist: Dispense with enclosed Medication Guide

CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

Rx only30 Capsules (3 x 10 Prescription Packs)

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2435-15

Isotretinoin Capsules, USP

30 mg

Each capsule contains 30 mg isotretinoin, USP

Attention Pharmacist: Dispense with enclosed Medication Guide

CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

Rx only30 Capsules (3 x 10 Prescription Packs)

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2501-15

Isotretinoin Capsules, USP

35 mg

Each capsule contains 35 mg isotretinoin, USP

Attention Pharmacist: Dispense with enclosed Medication Guide

CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

Rx only30 Capsules (3 x 10 Prescription Packs)

1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-2436-15

Isotretinoin Capsules, USP

40 mg

Each capsule contains 40 mg isotretinoin, USP

Attention Pharmacist: Dispense with enclosed Medication Guide

CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

Rx only30 Capsules (3 x 10 Prescription Packs)

1
(click image for full-size original)
ISOTRETINOIN isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2433
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 10 mg
Inactive Ingredients
Ingredient Name Strength
SORBITAN MONOOLEATE
SOYBEAN OIL
PEG-32 HYDROGENATED PALM GLYCERIDES
.ALPHA.-TOCOPHEROL
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white, blue (banded with a blue band) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code WPI;2433
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2433-15 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0591-2433-45)
1 NDC:0591-2433-45 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0591-2433-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205063 04/29/2021
ISOTRETINOIN isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2434
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 20 mg
Inactive Ingredients
Ingredient Name Strength
SORBITAN MONOOLEATE
SOYBEAN OIL
PEG-32 HYDROGENATED PALM GLYCERIDES
.ALPHA.-TOCOPHEROL
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white, yellow (light yellow) , blue (banded with a blue band) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code WPI;2434
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2434-15 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0591-2434-45)
1 NDC:0591-2434-45 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0591-2434-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205063 04/29/2021
ISOTRETINOIN isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2451
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 25 mg
Inactive Ingredients
Ingredient Name Strength
SORBITAN MONOOLEATE
SOYBEAN OIL
PEG-32 HYDROGENATED PALM GLYCERIDES
.ALPHA.-TOCOPHEROL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
FERROSOFERRIC OXIDE
SHELLAC
PROPYLENE GLYCOL
Product Characteristics
Color green (light green) , blue (banded with a blue band) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code WPI;A128
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2451-15 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0591-2451-45)
1 NDC:0591-2451-45 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0591-2451-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205063 04/29/2021
ISOTRETINOIN isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2435
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 30 mg
Inactive Ingredients
Ingredient Name Strength
SORBITAN MONOOLEATE
SOYBEAN OIL
PEG-32 HYDROGENATED PALM GLYCERIDES
.ALPHA.-TOCOPHEROL
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
POTASSIUM HYDROXIDE
Product Characteristics
Color orange, blue (banded with a blue band) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code WPI;2435
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2435-15 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0591-2435-45)
1 NDC:0591-2435-45 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0591-2435-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205063 04/29/2021
ISOTRETINOIN isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2501
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 35 mg
Inactive Ingredients
Ingredient Name Strength
SORBITAN MONOOLEATE
SOYBEAN OIL
PEG-32 HYDROGENATED PALM GLYCERIDES
.ALPHA.-TOCOPHEROL
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
FERROSOFERRIC OXIDE
SHELLAC
PROPYLENE GLYCOL
Product Characteristics
Color pink (flesh) , blue (banded with a blue band) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code WPI;A168
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2501-15 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0591-2501-45)
1 NDC:0591-2501-45 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0591-2501-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205063 04/29/2021
ISOTRETINOIN isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2436
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 40 mg
Inactive Ingredients
Ingredient Name Strength
SORBITAN MONOOLEATE
SOYBEAN OIL
PEG-32 HYDROGENATED PALM GLYCERIDES
.ALPHA.-TOCOPHEROL
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
POTASSIUM HYDROXIDE
Product Characteristics
Color orange, blue (banded with a blue band) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code WPI;2436
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2436-15 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0591-2436-45)
1 NDC:0591-2436-45 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0591-2436-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205063 04/29/2021
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 09/2020 Actavis Pharma, Inc.

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