Epuris: Package Insert / Prescribing Information - Drugs.com

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# Epuris

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

Medically reviewed by Drugs.com. Last updated on Jan 1, 2022.

## 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

Epuris isotretinoin capsule

Product Information
Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:66277-339
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
PROPYL GALLATE |
SOYBEAN OIL |
PEG-32 HYDROGENATED PALM GLYCERIDES |
SORBITAN MONOOLEATE |

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

Packaging
# | Item Code | Package Description
1 | NDC:66277-339-30 | 3 BLISTER PACK in 1 BOX
1 | NDC:66277-339-10 | 10 CAPSULE in 1 BLISTER PACK

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 LABEL | Item Code (Source) | NDC:66277-340
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
PROPYL GALLATE |
SOYBEAN OIL |
PEG-32 HYDROGENATED PALM GLYCERIDES |
SORBITAN MONOOLEATE |

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

Packaging
# | Item Code | Package Description
1 | NDC:66277-340-30 | 3 BLISTER PACK in 1 BOX
1 | NDC:66277-340-10 | 10 CAPSULE in 1 BLISTER PACK

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 LABEL | Item Code (Source) | NDC:66277-338
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
PROPYL GALLATE |
SOYBEAN OIL |
PEG-32 HYDROGENATED PALM GLYCERIDES |
SORBITAN MONOOLEATE |

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

Packaging
# | Item Code | Package Description
1 | NDC:66277-338-30 | 3 BLISTER PACK in 1 BOX
1 | NDC:66277-338-10 | 10 CAPSULE in 1 BLISTER PACK

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 LABEL | Item Code (Source) | NDC:66277-337
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
PROPYL GALLATE |
SOYBEAN OIL |
PEG-32 HYDROGENATED PALM GLYCERIDES |
SORBITAN MONOOLEATE |

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

Packaging
# | Item Code | Package Description
1 | NDC:66277-337-30 | 3 BLISTER PACK in 1 BOX
1 | NDC:66277-337-10 | 10 CAPSULE in 1 BLISTER PACK

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 | 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)

Galephar Pharmaceutical Research Inc.

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