NDC product

Sodium phenylbutyrate

NDC 68475-011 · Navinta LLC

Key facts

Product NDC 68475-011
Proprietary name Sodium phenylbutyrate
Nonproprietary name Sodium phenylbutyrate
Substances SODIUM PHENYLBUTYRATE
Dosage form TABLET
Route ORAL
Labeler Navinta LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA220418
Pharmacologic classes Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
Marketing start Jul 10, 2026
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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