Epuris
Approved
Approval ID
d6ba7a44-ca13-e001-e053-2995a90afe0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2022
Manufacturers
FDA
Galephar Pharmaceutical Research Inc.
DUNS: 003551624
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-340
Product Classification
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2022
FDA Product Classification
INGREDIENTS (5)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
ISOTRETINOINActive
Quantity: 40 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-338
Product Classification
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2022
FDA Product Classification
INGREDIENTS (5)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
ISOTRETINOINActive
Quantity: 20 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-339
Product Classification
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2022
FDA Product Classification
INGREDIENTS (5)
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
ISOTRETINOINActive
Quantity: 30 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-337
Product Classification
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2022
FDA Product Classification
INGREDIENTS (5)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
ISOTRETINOINActive
Quantity: 10 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/1/2020
Epuris 40 mg Box of 3 blister cards
