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Last Updated: December 11, 2025

List of Excipients in API isotretinoin


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Excipients in NDA-approved (novel) drugs containing isotretinoin

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
Sun Pharmaceutical Industries Inc ABSORICA isotretinoin 10631-115 FERRIC OXIDE YELLOW
Sun Pharmaceutical Industries Inc ABSORICA isotretinoin 10631-115 GELATIN
Sun Pharmaceutical Industries Inc ABSORICA isotretinoin 10631-115 PEG-32 HYDROGENATED PALM GLYCERIDES
Sun Pharmaceutical Industries Inc ABSORICA isotretinoin 10631-115 POTASSIUM HYDROXIDE
Sun Pharmaceutical Industries Inc ABSORICA isotretinoin 10631-115 PROPYL GALLATE
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing isotretinoin

Company Ingredient NDC Excipient
Upsher-Smith Laboratories LLC isotretinoin 0245-0570 .ALPHA.-TOCOPHEROL
Upsher-Smith Laboratories LLC isotretinoin 0245-0570 BUTYLATED HYDROXYANISOLE
Upsher-Smith Laboratories LLC isotretinoin 0245-0570 EDETATE DISODIUM
Upsher-Smith Laboratories LLC isotretinoin 0245-0570 FERRIC OXIDE YELLOW
Upsher-Smith Laboratories LLC isotretinoin 0245-0570 GELATIN
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for isotretinoin

Excipient focus: .ALPHA.-TOCOPHEROL

Excipient focus: .ALPHA.-TOCOPHEROL, DL-

Excipient focus: ALCOHOL

Excipient focus: ALPHA-TOCOPHEROL

Excipient focus: AMMONIA

Excipient focus: BUTYL ALCOHOL

Excipient focus: BUTYLATED HYDROXYANISOLE

Excipient focus: CORN OIL

Excipient focus: COTTONSEED OIL

Excipient focus: D&C RED NO. 27

Excipient focus: D&C RED NO. 30

Excipient focus: D&C RED NO. 7

Excipient focus: D&C YELLOW NO. 10

Excipient focus: DEHYDRATED ALCOHOL

Excipient focus: DIMETHICONE

Excipient focus: EDETATE DISODIUM

Excipient focus: FD&C BLUE NO. 1

Excipient focus: FD&C BLUE NO. 2

Excipient focus: FD&C RED NO. 40

Excipient focus: FD&C YELLOW NO. 6

Excipient focus: FERRIC OXIDE RED

Excipient focus: FERRIC OXIDE YELLOW

Excipient focus: FERROSOFERRIC OXIDE

Excipient focus: GELATIN

Excipient focus: GLYCERIN

Excipient focus: HYDROGENATED SOYBEAN OIL

Excipient focus: ISOPROPYL ALCOHOL

Excipient focus: MEDIUM-CHAIN TRIGLYCERIDES

Excipient focus: METHYLPARABEN

Excipient focus: PEG-32 HYDROGENATED PALM GLYCERIDES

Excipient focus: POLYETHYLENE GLYCOL 400

Excipient focus: POLYSORBATE 80

Excipient focus: POLYVINYL ACETATE PHTHALATE

Excipient focus: POTASSIUM HYDROXIDE

Excipient focus: PROPYL GALLATE

Excipient focus: PROPYLENE GLYCOL

Excipient focus: PROPYLPARABEN

Excipient focus: SHELLAC

Excipient focus: SORBITAN MONOOLEATE

Excipient focus: SORBITOL

Excipient focus: SOYBEAN OIL

Excipient focus: STEAROYL POLYOXYL-32 GLYCERIDES

Excipient focus: TITANIUM DIOXIDE

Excipient focus: WATER

Excipient focus: WHITE WAX

Excipient focus: YELLOW WAX

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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