NDC Code(s) : 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055-56, 0555-1056-60, 0555-1056-86, 0555-1057-60, 0555-1057-56, 0555-1057-86
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ClaravisIsotretinoin CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-1054
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN(UNII: EH28UP18IF)
(ISOTRETINOIN - UNII:EH28UP18IF) 		ISOTRETINOIN10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SOYBEAN OIL(UNII: 241ATL177A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WHITE WAX(UNII: 7G1J5DA97F)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C RED NO. 7(UNII: ECW0LZ41X8)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color gray (light gray) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code barr;934
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0555-1054-863 in 1 CARTON 05/09/2003
1NDC:0555-1054-6010 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0555-1054-5610 in 1 CARTON 05/09/2003
2NDC:0555-1054-6010 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076356 05/09/2003
ClaravisIsotretinoin CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-1055
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN(UNII: EH28UP18IF)
(ISOTRETINOIN - UNII:EH28UP18IF) 		ISOTRETINOIN20 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SOYBEAN OIL(UNII: 241ATL177A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WHITE WAX(UNII: 7G1J5DA97F)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
AMMONIA(UNII: 5138Q19F1X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
DIMETHICONE 350(UNII: 2Y53S6ATLU)
SILICA, TRIMETHYLSILYL CAPPED(UNII: VU10KU4B9S)
Product Characteristics
Color brown Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code barr;935
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0555-1055-863 in 1 CARTON 05/09/2003
1NDC:0555-1055-6010 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0555-1055-5610 in 1 CARTON 05/09/2003
2NDC:0555-1055-6010 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076135 05/09/2003
ClaravisIsotretinoin CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-1056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN(UNII: EH28UP18IF)
(ISOTRETINOIN - UNII:EH28UP18IF) 		ISOTRETINOIN30 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SOYBEAN OIL(UNII: 241ATL177A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WHITE WAX(UNII: 7G1J5DA97F)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code barr;454
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0555-1056-863 in 1 CARTON 18/05/2006
1NDC:0555-1056-6010 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076135 05/18/2006
ClaravisIsotretinoin CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-1057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOTRETINOIN(UNII: EH28UP18IF)
(ISOTRETINOIN - UNII:EH28UP18IF) 		ISOTRETINOIN40 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SOYBEAN OIL(UNII: 241ATL177A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WHITE WAX(UNII: 7G1J5DA97F)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color orange (light orange) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code barr;936
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0555-1057-5610 in 1 CARTON 05/09/2003
1NDC:0555-1057-6010 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0555-1057-863 in 1 CARTON 05/09/2003
2NDC:0555-1057-6010 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076135 05/09/2003

LABELER - Teva Pharmaceuticals USA, Inc.(001627975)

PRINCIPAL DISPLAY PANEL

Rx only

NDC 0555-1054-86

ClaravisTM

(isotretinoin capsules USP)

Each capsule contains 10 mg isotretinoin, USP

10 mg

Protect from Light

3 Prescription Blister Packs

of 10 Capsules Each (30 Capsules)

CONTRAINDICATED IN PREGNANCY

PHARMACIST: DISPENSE PRESCRIPTION BLISTER PACKS INTACT.

Blister pack complies with child-resistant packaging requirements.

Usual Dosage: See package brochure and other important prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454

Claravis (isotretinoin capsules USP) 10 mg 30s Carton, Part 1 of 2

PRINCIPAL DISPLAY PANEL

Claravis (isotretinoin capsules USP) 10 mg 30s Carton, Part 2 of 2

PRINCIPAL DISPLAY PANEL

Rx only

NDC 0555-1055-86

ClaravisTM

(isotretinoin capsules USP)

Each capsule contains 20 mg isotretinoin, USP

20 mg

Protect from Light

3 Prescription Blister Packs

of 10 Capsules Each (30 Capsules)

CONTRAINDICATED IN PREGNANCY

PHARMACIST: DISPENSE PRESCRIPTION BLISTER PACKS INTACT.

Blister pack complies with child-resistant packaging requirements.

Usual Dosage: See package brochure and other important prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454

Claravis (isotretinoin capsules USP) 20 mg 30s Carton, Part 1 of 2

PRINCIPAL DISPLAY PANEL

Claravis (isotretinoin capsules USP) 20 mg 30s Carton, Part 2 of 2

PRINCIPAL DISPLAY PANEL

Rx only

NDC 0555-1056-86

ClaravisTM

(isotretinoin capsules USP)

Each capsule contains 30 mg isotretinoin, USP

30 mg

Protect from Light

3 Prescription Blister Packs

of 10 Capsules Each (30 Capsules)

CONTRAINDICATED IN PREGNANCY

PHARMACIST: DISPENSE PRESCRIPTION BLISTER PACKS INTACT.

Blister pack complies with child-resistant packaging requirements.

Usual Dosage: See package brochure and other important prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454

Claravis (isotretinoin capsules USP) 30 mg 30s Carton, Part 1 of 2

PRINCIPAL DISPLAY PANEL

Claravis (isotretinoin capsules USP) 30 mg 30s Carton, Part 2 of 2

PRINCIPAL DISPLAY PANEL

Rx only

NDC 0555-1057-86

ClaravisTM

(isotretinoin capsules USP)

Each capsule contains 40 mg isotretinoin, USP

40 mg

Protect from Light

3 Prescription Blister Packs

of 10 Capsules Each (30 Capsules)

CONTRAINDICATED IN PREGNANCY

PHARMACIST: DISPENSE PRESCRIPTION BLISTER PACKS INTACT.

Blister pack complies with child-resistant packaging requirements.

Usual Dosage: See package brochure and other important prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454

Claravis (isotretinoin capsules USP) 40 mg 30s Carton, Part 1 of 2

PRINCIPAL DISPLAY PANEL

Claravis (isotretinoin capsules USP) 40 mg 30s Carton, Part 2 of 2