Isotretinoin Capsules, USP Rx Only CAUSES BIRTH DEFECTS

Label at a glance#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1557-8

Isotretinoin Capsules, USP 10 mg

30 Capsules

Rx only

NDC 70771-1558-8

Isotretinoin Capsules, USP 20 mg

30 Capsules

Rx only

NDC 70771-1559-8

Isotretinoin Capsules, USP 30 mg

30 Capsules

Rx only

NDC 70771-1560-8

Isotretinoin Capsules, USP 40 mg

30 Capsules

Rx only

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

• Isotretinoin
• ALCOHOL
• AMMONIA
• BUTYLATED HYDROXYANISOLE
• EDETATE DISODIUM
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW
• FERROSOFERRIC OXIDE
• GELATIN
• GLYCERIN
• HYDROGENATED SOYBEAN OIL
• ISOPROPYL ALCOHOL
• POLYETHYLENE GLYCOL 400
• POLYVINYL ACETATE PHTHALATE
• PROPYLENE GLYCOL
• SOYBEAN OIL
• TITANIUM DIOXIDE
• WATER
• WHITE WAX

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 76 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 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 3 · 92 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

openFDA label cross-check#

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

Reported adverse events (FAERS/openFDA)#

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