Label: EPURIS- isotretinoin capsule
- NDC Code(s): 66277-335-10, 66277-335-30, 66277-336-10, 66277-336-30
- Packager: Galephar Pharmaceutical Research Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated October 4, 2023
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- Official Label (Printer Friendly)
- Epuris 10 mg Box of 3 blister cards
- Epuris 20 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:66277-335 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:66277-335-30 3 in 1 BOX 10/01/2023 1 NDC:66277-335-10 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 10/01/2023 EPURIS
isotretinoin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66277-336 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:66277-336-30 3 in 1 BOX 10/01/2023 1 NDC:66277-336-10 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 10/01/2023 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(66277-335, 66277-336) , manufacture(66277-335, 66277-336) , pack(66277-335, 66277-336)
