Isotretinoin
These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
b44200ba-6672-4ea7-b151-7caec3f53c9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 6
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 Code57664-025
Application NumberNDA021951
Product Classification
M
Marketing Category
C73605
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (14)
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ISOTRETINOINActive
Quantity: 40 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-024
Application NumberNDA021951
Product Classification
M
Marketing Category
C73605
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (14)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
ISOTRETINOINActive
Quantity: 35 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-023
Application NumberNDA021951
Product Classification
M
Marketing Category
C73605
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (14)
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ISOTRETINOINActive
Quantity: 30 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-021
Application NumberNDA021951
Product Classification
M
Marketing Category
C73605
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ISOTRETINOINActive
Quantity: 20 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-022
Application NumberNDA021951
Product Classification
M
Marketing Category
C73605
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (13)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ISOTRETINOINActive
Quantity: 25 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-020
Application NumberNDA021951
Product Classification
M
Marketing Category
C73605
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (11)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ISOTRETINOINActive
Quantity: 10 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB