Isotretinoin

Label at a glance#

Label contents#

Full prescribing information#

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

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

• 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
• D&C YELLOW NO. 10
• FD&C RED NO. 40
• FD&C BLUE NO. 1
• FD&C RED NO. 3
• FERRIC OXIDE RED

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 84 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.