Epuris: Package Insert / Prescribing Info

Package insert / product label
Generic name: isotretinoin
Dosage form: capsule
Drug classes: Miscellaneous antineoplastics, Miscellaneous uncategorized agents

Medically reviewed by Drugs.com. Last updated on Jan 23, 2025.

Epuris 10 mg Box of 3 blister cards

Epuris 20 mg Box of 3 blister cards

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Epuris 30 mg Box of 3 blister cards

Epuris 40 mg Box of 3 blister cards

EPURIS
isotretinoin capsule

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		05/07/2013

Labeler - Galephar Pharmaceutical Research Inc. (003551624)

Registrant - Galephar Pharmaceutical Research Inc. (968996160)

Name	Address	ID/FEI	Business Operations
Establishment
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)