EPURIS- isotretinoin capsule

Epuris by

Drug Labeling and Warnings

Epuris by is a Prescription medication manufactured, distributed, or labeled by Galephar Pharmaceutical Research Inc., Galephar Pharmaceutical Research Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Epuris 10 mg Box of 3 blister cards

Epuris 20 mg Box of 3 blister cards

Epuris 30 mg Box of 3 blister cards

Epuris 40 mg Box of 3 blister cards

INGREDIENTS AND APPEARANCE

EPURIS 
isotretinoin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66277-339
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF)	ISOTRETINOIN	30 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Product Characteristics
Color	brown	Score	no score
Shape	CAPSULE	Size	23mm
Flavor		Imprint Code	G242;30
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-339-30	3 in 1 BOX	05/07/2013
1	NDC: 66277-339-10	10 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
Export only		05/07/2013

EPURIS 
isotretinoin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66277-340
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF)	ISOTRETINOIN	40 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Product Characteristics
Color	brown, red	Score	no score
Shape	CAPSULE	Size	26mm
Flavor		Imprint Code	G325;40
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-340-30	3 in 1 BOX	05/07/2013
1	NDC: 66277-340-10	10 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
Export only		05/07/2013

EPURIS 
isotretinoin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66277-338
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF)	ISOTRETINOIN	20 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	G241;20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-338-30	3 in 1 BOX	05/07/2013
1	NDC: 66277-338-10	10 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
Export only		05/07/2013

EPURIS 
isotretinoin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66277-337
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF)	ISOTRETINOIN	10 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	G240;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-337-30	3 in 1 BOX	05/07/2013
1	NDC: 66277-337-10	10 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
Export only		05/07/2013

Labeler - Galephar Pharmaceutical Research Inc. (003551624)

Registrant - Galephar Pharmaceutical Research Inc. (968996160)

Establishment
Name	Address	ID/FEI	Business Operations
Galephar Pharmaceutical Research Inc		968996160	analysis(66277-337, 66277-338, 66277-339, 66277-340) , manufacture(66277-337, 66277-338, 66277-339, 66277-340) , pack(66277-337, 66277-338, 66277-339, 66277-340)