Isotretinoin

Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg

Approved

Approval ID

c369e1c3-90c5-4768-9741-56c62253a2c4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 23, 2023

Manufacturers

FDA

Upsher-Smith Laboratories, LLC

DUNS: 047251004

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 Code0832-8304

Application NumberANDA076485

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateJune 8, 2023

FDA Product Classification

INGREDIENTS (19)

IsotretinoinActive

Quantity: 40 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

yellow waxInactive

Code: 2ZA36H0S2V

Classification: IACT

butylated hydroxyanisoleInactive

Code: REK4960K2U

Classification: IACT

edetate disodiumInactive

Code: 7FLD91C86K

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

hydrogenated soybean oilInactive

Code: A2M91M918C

Classification: IACT

.ALPHA.-tocopherol, DL-Inactive

Code: 7QWA1RIO01

Classification: IACT

soybean oilInactive

Code: 241ATL177A

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

Isotretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0832-8303

Application NumberANDA076485

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateJune 8, 2023

FDA Product Classification

INGREDIENTS (19)

IsotretinoinActive

Quantity: 30 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

yellow waxInactive

Code: 2ZA36H0S2V

Classification: IACT

butylated hydroxyanisoleInactive

Code: REK4960K2U

Classification: IACT

edetate disodiumInactive

Code: 7FLD91C86K

Classification: IACT

hydrogenated soybean oilInactive

Code: A2M91M918C

Classification: IACT

.ALPHA.-tocopherol, DL-Inactive

Code: 7QWA1RIO01

Classification: IACT

soybean oilInactive

Code: 241ATL177A

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

Isotretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0832-8302

Application NumberANDA076485

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateJune 8, 2023

FDA Product Classification

INGREDIENTS (18)

edetate disodiumInactive

Code: 7FLD91C86K

Classification: IACT

hydrogenated soybean oilInactive

Code: A2M91M918C

Classification: IACT

.ALPHA.-tocopherol, DL-Inactive

Code: 7QWA1RIO01

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

IsotretinoinActive

Quantity: 20 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

yellow waxInactive

Code: 2ZA36H0S2V

Classification: IACT

butylated hydroxyanisoleInactive

Code: REK4960K2U

Classification: IACT

soybean oilInactive

Code: 241ATL177A

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

Isotretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0832-8301

Application NumberANDA076485

Product Classification

Marketing Category

C73584

Generic Name

Isotretinoin

Product Specifications

Route of AdministrationORAL

Effective DateJune 8, 2023

FDA Product Classification

INGREDIENTS (19)

IsotretinoinActive

Quantity: 10 mg in 1 1

Code: EH28UP18IF

Classification: ACTIB

yellow waxInactive

Code: 2ZA36H0S2V

Classification: IACT

butylated hydroxyanisoleInactive

Code: REK4960K2U

Classification: IACT

edetate disodiumInactive

Code: 7FLD91C86K

Classification: IACT

hydrogenated soybean oilInactive

Code: A2M91M918C

Classification: IACT

.ALPHA.-tocopherol, DL-Inactive

Code: 7QWA1RIO01

Classification: IACT

soybean oilInactive

Code: 241ATL177A

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

glycerinInactive

Code: PDC6A3C0OX

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

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 (18)

Isotretinoin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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