ACCUTANE
Isotretinoin Capsules USP
Approved
Approval ID
5b524a51-a16b-496e-b764-11c98c479c36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
JG Pharma Inc.
DUNS: 081048334
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 Code72143-253
Application NumberANDA202099
Product Classification
M
Marketing Category
C73584
G
Generic Name
ISOTRETINOIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (18)
ISOTRETINOINActive
Quantity: 30 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOTRETINOIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72143-254
Application NumberANDA202099
Product Classification
M
Marketing Category
C73584
G
Generic Name
ISOTRETINOIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (18)
ISOTRETINOINActive
Quantity: 40 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOTRETINOIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72143-251
Application NumberANDA202099
Product Classification
M
Marketing Category
C73584
G
Generic Name
ISOTRETINOIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (18)
ISOTRETINOINActive
Quantity: 10 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Fd&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOTRETINOIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72143-252
Application NumberANDA202099
Product Classification
M
Marketing Category
C73584
G
Generic Name
ISOTRETINOIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (18)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ISOTRETINOINActive
Quantity: 20 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT