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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, 2024.

Epuris 10 mg Box of 3 blister cards

Epuris 10 mg Box of 3 blister cards

Epuris 20 mg Box of 3 blister cards

Epuris 20 mg Box of 3 blister cards

Epuris 30 mg Box of 3 blister cards

Epuris 30 mg Box of 3 blister cards

Epuris 40 mg Box of 3 blister cards

Epuris 40 mg Box of 3 blister cards

EPURIS
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-339
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN30 mg
Inactive Ingredients
Ingredient NameStrength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
Product Characteristics
ColorbrownScoreno score
ShapeCAPSULESize23mm
FlavorImprint CodeG242;30
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-339-303 in 1 BOX05/07/2013
1NDC:66277-339-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/07/2013
EPURIS
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-340
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN40 mg
Inactive Ingredients
Ingredient NameStrength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
Product Characteristics
Colorbrown, redScoreno score
ShapeCAPSULESize26mm
FlavorImprint CodeG325;40
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-340-303 in 1 BOX05/07/2013
1NDC:66277-340-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/07/2013
EPURIS
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-338
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN20 mg
Inactive Ingredients
Ingredient NameStrength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeG241;20
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-338-303 in 1 BOX05/07/2013
1NDC:66277-338-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/07/2013
EPURIS
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-337
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN10 mg
Inactive Ingredients
Ingredient NameStrength
PROPYL GALLATE (UNII: 8D4SNN7V92)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
Product Characteristics
ColoryellowScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeG240;10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-337-303 in 1 BOX05/07/2013
1NDC:66277-337-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/07/2013
Labeler - Galephar Pharmaceutical Research Inc. (003551624)
Registrant - Galephar Pharmaceutical Research Inc. (968996160)
Establishment
NameAddressID/FEIBusiness Operations
Galephar Pharmaceutical Research Inc968996160analysis(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)

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