United States · FDA National Drug Code directory

Sodium phenylbutyrate

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
68475-011_5da41af8-4b7d-4703-9e7e-8b4d7ffed8b6
Product NDC
68475-011
Form
TABLET
Composition / generic term
Sodium phenylbutyrate
Labeler
Navinta LLC
Marketing category
ANDA
Marketing start / end (source format)
20260710
Source listing expiry
20271231

Source-listed ingredients

  • SODIUM PHENYLBUTYRATE — 500 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 BOTTLE in 1 CARTON (68475-011-01) / 250 TABLET in 1 BOTTLE · 68475-011-01

Source and coverage

Open FDA National Drug Code directory

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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