Isotretinoin

Isotretinoin Capsules, USP Rx Only

Approved

Approval ID

28948c32-a598-4bb5-bdb5-efbd87214d98

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 1, 2023

Manufacturers

FDA

Zydus Pharmaceuticals USA Inc.

DUNS: 156861945

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 Code70710-1022

Application NumberANDA211568

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 1, 2023

FDA Product Classification

INGREDIENTS (19)

ISOTRETINOINActive

Quantity: 10 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86K

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918C

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYVINYL ACETATE PHTHALATEInactive

Code: 58QVG85GW3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

WHITE WAXInactive

Code: 7G1J5DA97F

Classification: IACT

Isotretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70710-1025

Application NumberANDA211568

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 1, 2023

FDA Product Classification

INGREDIENTS (19)

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ISOTRETINOINActive

Quantity: 40 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86K

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918C

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYVINYL ACETATE PHTHALATEInactive

Code: 58QVG85GW3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

WHITE WAXInactive

Code: 7G1J5DA97F

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

Isotretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70710-1024

Application NumberANDA211568

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 1, 2023

FDA Product Classification

INGREDIENTS (19)

ISOTRETINOINActive

Quantity: 30 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918C

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WHITE WAXInactive

Code: 7G1J5DA97F

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYVINYL ACETATE PHTHALATEInactive

Code: 58QVG85GW3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86K

Classification: IACT

Isotretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70710-1023

Application NumberANDA211568

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 1, 2023

FDA Product Classification

INGREDIENTS (19)

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2U

Classification: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86K

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918C

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYVINYL ACETATE PHTHALATEInactive

Code: 58QVG85GW3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ISOTRETINOINActive

Quantity: 20 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

WHITE WAXInactive

Code: 7G1J5DA97F

Classification: IACT

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Isotretinoin

Products 4

Isotretinoin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Isotretinoin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Isotretinoin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Isotretinoin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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