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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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