This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Isotretinoin

Read time: 1 mins
Marketing start date: 12 Jul 2025
...
 

Summary of product characteristics


Effective Time

20250604

Version

1

Spl Product Data Elements

Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN PEG-32 HYDROGENATED PALM GLYCERIDES POTASSIUM HYDROXIDE PROPYL GALLATE PROPYLENE GLYCOL SHELLAC SORBITAN MONOOLEATE SOYBEAN OIL TITANIUM DIOXIDE WATER yellow opaque cap yellow opaque body 1574 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN D&C YELLOW NO. 10 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN PEG-32 HYDROGENATED PALM GLYCERIDES POTASSIUM HYDROXIDE PROPYL GALLATE PROPYLENE GLYCOL SHELLAC SORBITAN MONOOLEATE SOYBEAN OIL TITANIUM DIOXIDE WATER orange opaque cap orange opaque body 1575 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN PEG-32 HYDROGENATED PALM GLYCERIDES POTASSIUM HYDROXIDE PROPYL GALLATE PROPYLENE GLYCOL SHELLAC SORBITAN MONOOLEATE SOYBEAN OIL TITANIUM DIOXIDE WATER light green opaque cap light green opaque body 1576 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN D&C YELLOW NO. 10 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN PEG-32 HYDROGENATED PALM GLYCERIDES POTASSIUM HYDROXIDE PROPYL GALLATE PROPYLENE GLYCOL SHELLAC SORBITAN MONOOLEATE SOYBEAN OIL TITANIUM DIOXIDE WATER light brown opaque cap light brown opaque body 1577 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN FD&C BLUE NO. 1 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN PEG-32 HYDROGENATED PALM GLYCERIDES POTASSIUM HYDROXIDE PROPYL GALLATE PROPYLENE GLYCOL SHELLAC SORBITAN MONOOLEATE SOYBEAN OIL TITANIUM DIOXIDE WATER light blue opaque cap light blue opaque body 1578 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN PEG-32 HYDROGENATED PALM GLYCERIDES POTASSIUM HYDROXIDE PROPYL GALLATE PROPYLENE GLYCOL SHELLAC SORBITAN MONOOLEATE SOYBEAN OIL TITANIUM DIOXIDE WATER light pink opaque cap light pink opaque body 1579

Application Number

ANDA216633

Brand Name

Isotretinoin

Generic Name

Isotretinoin

Product Ndc

70771-1663

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1662-8 Isotretinoin Capsules USP, 10 mg 30 Capsules Rx only NDC 70771-1663-8 Isotretinoin Capsules USP, 20 mg 30 Capsules Rx only NDC 70771-1664-8 Isotretinoin Capsules USP, 25 mg 30 Capsules Rx only NDC 70771-1665-8 Isotretinoin Capsules USP, 30 mg 30 Capsules Rx only NDC 70771-1666-8 Isotretinoin Capsules USP, 35 mg 30 Capsules Rx only NDC 70771-1667-8 Isotretinoin Capsules USP, 40 mg 30 Capsules Rx only 10 mg 10 mg 20 mg 20 mg 25 mg 25 mg 30 mg 30 mg 35 mg 35 mg 40 mg 40 mg

Spl Medguide

SPL MEDGUIDE

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.