Isotretinoin
Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg Rx Only
Approved
Approval ID
c2917c3d-3499-48a0-ba53-120cb979195d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-1176
Application NumberANDA207792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (10)
ISOTRETINOINActive
Quantity: 40 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1017
Application NumberANDA207792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (10)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
ISOTRETINOINActive
Quantity: 30 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1174
Application NumberANDA207792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (11)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ISOTRETINOINActive
Quantity: 10 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1175
Application NumberANDA207792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (12)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ISOTRETINOINActive
Quantity: 20 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT