Absorica (Page 11 of 11)

Absorica LD 32mg Blister

PDP-32mg Wallet
(click image for full-size original)

Absorica LD 32mg Carton

PDP-32mg carton
(click image for full-size original)
ABSORICA isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-115
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
SOYBEAN OIL
SORBITAN MONOOLEATE
PROPYL GALLATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
PEG-32 HYDROGENATED PALM GLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code G240;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-115-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK (10631-115-69)
1 NDC:10631-115-69 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-115-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021951 06/08/2012
ABSORICA isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-116
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
SOYBEAN OIL
SORBITAN MONOOLEATE
PROPYL GALLATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
PEG-32 HYDROGENATED PALM GLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color red Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code G241;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-116-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK (10631-116-69)
1 NDC:10631-116-69 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-116-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021951 06/08/2012
ABSORICA isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-117
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
SOYBEAN OIL
SORBITAN MONOOLEATE
PROPYL GALLATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
PEG-32 HYDROGENATED PALM GLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color brown Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code G242;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-117-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK (10631-117-69)
1 NDC:10631-117-69 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-117-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021951 06/08/2012
ABSORICA isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-118
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
SOYBEAN OIL
SORBITAN MONOOLEATE
PROPYL GALLATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
PEG-32 HYDROGENATED PALM GLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color brown, red Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code G325;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-118-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK (10631-118-69)
1 NDC:10631-118-69 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-118-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021951 06/08/2012
ABSORICA isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-133
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
SOYBEAN OIL
SORBITAN MONOOLEATE
PROPYL GALLATE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
PEG-32 HYDROGENATED PALM GLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color green Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code G342;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-133-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK (10631-133-69)
1 NDC:10631-133-69 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-133-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021951 02/17/2015
ABSORICA isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-134
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
SOYBEAN OIL
SORBITAN MONOOLEATE
PROPYL GALLATE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
PEG-32 HYDROGENATED PALM GLYCERIDES
GELATIN, UNSPECIFIED
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code G343;35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-134-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK (10631-134-69)
1 NDC:10631-134-69 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-134-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021951 02/17/2015
ABSORICA LD isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 8 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
GELATIN, UNSPECIFIED
POLYSORBATE 80
SOYBEAN OIL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (light green) Score no score
Shape CAPSULE (opaque-printed, hard-gelatin) Size 16mm
Flavor Imprint Code RL29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-002-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-002-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211913 11/20/2019
ABSORICA LD isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 16 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
GELATIN, UNSPECIFIED
POLYSORBATE 80
SOYBEAN OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (dark blue) Score no score
Shape CAPSULE (opaque-printed, hard-gelatin) Size 18mm
Flavor Imprint Code RL30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-003-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-003-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211913 11/20/2019
ABSORICA LD isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-004
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
BUTYLATED HYDROXYANISOLE
GELATIN, UNSPECIFIED
POLYSORBATE 80
SOYBEAN OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color PINK (dark pink) Score no score
Shape CAPSULE (opaque-printed, hard-gelatin) Size 20mm
Flavor Imprint Code RL33
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-004-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-004-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211913 11/20/2019 11/20/2019
ABSORICA LD isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 24 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
GELATIN, UNSPECIFIED
POLYSORBATE 80
SOYBEAN OIL
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (opaque-printed, hard-gelatin) Size 20mm
Flavor Imprint Code RL31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-005-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-005-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211913 11/20/2019
ABSORICA LD isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 28 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
GELATIN, UNSPECIFIED
POLYSORBATE 80
SOYBEAN OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (light blue) Score no score
Shape CAPSULE (opaque-printed, hard-gelatin) Size 22mm
Flavor Imprint Code RL34
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-006-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-006-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211913 11/20/2019 11/20/2019
ABSORICA LD isotretinoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-007
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN (ISOTRETINOIN) ISOTRETINOIN 32 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
GELATIN, UNSPECIFIED
POLYSORBATE 80
SOYBEAN OIL
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (Caramel) Score no score
Shape CAPSULE (opaque-printed, hard-gelatin) Size 22mm
Flavor Imprint Code RL32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10631-007-31 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX (10631-007-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211913 11/20/2019
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Galephar Pharmaceutical Research Inc. 968996160 MANUFACTURE (10631-115), MANUFACTURE (10631-116), MANUFACTURE (10631-117), MANUFACTURE (10631-118), MANUFACTURE (10631-133), MANUFACTURE (10631-134)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE (10631-002), MANUFACTURE (10631-003), MANUFACTURE (10631-004), MANUFACTURE (10631-005), MANUFACTURE (10631-006), MANUFACTURE (10631-007)

Revised: 06/2020 Sun Pharmaceutical Industries, Inc.

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