United States · FDA National Drug Code directory

Isotretinoin

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference: 57664-024_0e924cf6-5375-28c4-e063-6294a90a4ac4
Product NDC: 57664-024
Form: CAPSULE
Composition / generic term: Isotretinoin
Labeler: Sun Pharmaceutical Industries, Inc.
Marketing category: NDA AUTHORIZED GENERIC
Marketing start / end (source format): 20201229
Source listing expiry: 20261231

Source-listed ingredients

ISOTRETINOIN — 35 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

3 BLISTER PACK in 1 BOX (57664-024-97) / 10 CAPSULE in 1 BLISTER PACK (57664-024-98) · 57664-024-97

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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