Label: EPURIS- isotretinoin capsule
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NDC Code(s):
66277-337-10,
66277-337-30,
66277-338-10,
66277-338-30, view more66277-339-10, 66277-339-30, 66277-340-10, 66277-340-30
- Packager: Galephar Pharmaceutical Research Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated December 6, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
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INGREDIENTS AND APPEARANCE
EPURIS
isotretinoin capsuleProduct 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 capsuleProduct 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 capsuleProduct 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 capsuleProduct 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)
